NEIL MEDICAL GROUP
Registration 1058397FEI 1000158532Kinston, NC
Owner/operator: Neil Medical Group
- Repack or Relabel Medical Device
Renewal due by December 31, 2026
Registered through 2026. Renew between October 1 and December 31, 2026, to stay registered for 2027.
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The 2026 window
- Oct 1Window opens91 days left
- Nov 3Where you stand58 days left
- Dec 1Our pay-by date30 days left
- Dec 15Two weeks left16 days left
- Dec 23Holiday week8 days left
- Dec 29Two days left2 days left
- Dec 31Window closes0 days left
- FDA fee, FY2027
- $13,785
- Our pay-by suggestion
- Dec 1
- Listed devices
- 21
- Added, last 12 months
- 9
FDA sets who pays the fee and who may qualify for a waiver; its fee page says so. The fee is paid only on FDA’s own fee site. Never through us. FDA’s fee page
The steps, in order
Pay FDA's annual feeYou
Order and pay the FY2027 establishment fee on FDA's Device Facility User Fee site. FDA emails you a PIN when you order.
FDA: registration and listing payment processWait for the payment confirmation numberYou
FDA emails a Payment Confirmation Number (PCN) once the payment processes, which FDA says typically takes several days. That is why we suggest paying by December 1.
FDA: registration and listing payment processRenew the registration in FDA's systemYou
Sign in to FDA's Unified Registration and Listing System (FURLS), complete the annual registration and apply your PIN and PCN. FDA does not count the registration as complete until both are applied.
FDA: device registration and listingReview every listingYou
In the same window, review each listing on file and report any changes, deletions and new listings. Your Listing Review Sheet puts every listing on one page.
FDA: device registration and listing
Every listed device 21
| Code | Device | Class | Regulation | Premarket |
|---|---|---|---|---|
| EZL | PRE-FILLED SYRINGECatheter, Retention Type, BalloonAdded Dec 4, 2025 | Class 2 | 21 CFR 876.5130 | K202698 |
| PIF | ENTERAL DELIVERY GRAVITY BAG W/ ENFITGastrointestinal Tubes With Enteral Specific ConnectorsAdded Dec 4, 2025 | Class 2 | 21 CFR 876.5980 | K240039 |
| FXX | Isolation MaskMask, Surgical | Class 2 | 21 CFR 878.4040 | K202708 |
| DQA | Pulse QximeterOximeter | Class 2 | 21 CFR 870.2700 | K082641 |
| KNT | ENTERAL DELIVERY GRAVITY BAG W/ ENFITTubes, Gastrointestinal (And Accessories)Added Dec 4, 2025 | Class 2 | 21 CFR 876.5980 | K240039 |
| FCN | URETHRAL CATH TRAY 14FR PVC CATHUrinary Drainage Collection Kit, For Indwelling CatheterAdded Dec 4, 2025 | Class 2 | 21 CFR 876.5250 | — |
| FAQ | URINARY LEG BAGBag, Urine Collection, Leg, For External Use, SterileAdded Dec 4, 2025 | Class 1 | 21 CFR 876.5250 | — |
| QDO | Exam Grade Blue NitrileFentanyl And Other Opioid Protection GloveAdded Jan 12, 2026 | Class 1 | 21 CFR 880.6250 | K243441 |
| LZC | Exam Grade Blue NitrileMedical Glove, SpecialtyAdded Jan 12, 2026 | Class 1 | 21 CFR 880.6250 | K243441 |
| OPJ | Exam Grade Blue NitrileMedical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy DrugsAdded Jan 12, 2026 | Class 1 | 21 CFR 880.6250 | K243441 |
| OEA | Isolation GownsNon-Surgical Gown | Class 1 | 21 CFR 878.4040 | — |
| LZA | Exam Grade Blue NitrilePolymer Patient Examination Glove | Class 1 | 21 CFR 880.6250 | K231439 |
and 9 more on your full dossier
What changed
- Dec 4, 2025Listing added: EZL — PRE-FILLED SYRINGE (K202698)
- Dec 4, 2025Listing added: PIF — ENTERAL DELIVERY GRAVITY BAG W/ ENFIT (K240039)
- Dec 4, 2025Listing added: KNT — ENTERAL DELIVERY GRAVITY BAG W/ ENFIT (K240039)
- Dec 4, 2025Listing added: FCN — URETHRAL CATH TRAY 14FR PVC CATH
- Dec 4, 2025Listing added: FAQ — URINARY LEG BAG
- Jan 12, 2026Listing added: QDO — Exam Grade Blue Nitrile (K243441)
- Jan 12, 2026Listing added: LZC — Exam Grade Blue Nitrile (K243441)
- Jan 12, 2026Listing added: OPJ — Exam Grade Blue Nitrile (K243441)
- Jan 12, 2026Listing added: LZA — Exam Grade Blue Nitrile (K243441)