MEDLINE INDUSTRIES, LP - Laredo
Registration 3005595283FEI 3005595283LAREDO, TX
Owner/operator: Medline Industries, LP
- Manufacture Device in the United States for Export Only
- Manufacture Medical Device
- Repack or Relabel Medical Device
- Reprocess Single-Use 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
- 101
- Added, last 12 months
- 0
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 101
| Code | Device | Class | Regulation | Premarket |
|---|---|---|---|---|
| DTL | MEDLINE ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS - DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | Class 2 | 21 CFR 870.4290 | K120069 |
| DTL | MEDLINE ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASSAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | Class 2 | 21 CFR 870.4290 | — |
| OEQ | Medline Angiography/Angioplasty KitAngiography/Angioplasty Kit | Class 2 | 21 CFR 870.1650 | — |
| GCX | MEDLINE APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED - GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered | Class 2 | 21 CFR 880.6740 | — |
| OII | Medline / CDS arthrogram trayArthrogram Tray | Class 2 | 21 CFR 892.1650 | — |
| OHH | Colostrum Collect StoreBreast Pump Kit | Class 2 | 21 CFR 884.5160 | — |
| OES | Medline / CDS cardiac catheterization kitCardiac Catheterization Kit | Class 2 | 21 CFR 870.1200 | — |
| OEZ | Medline Cardiovascular Procedure KitCardiovascular Procedure Kit | Class 2 | 21 CFR 870.1200 | — |
| OHR | Medline / CDS catheter care tray (kit)Catheter Care Tray | Class 2 | 21 CFR 876.5130 | — |
| OFD | Medline / CDS catheter introducer kitCatheter Introducer Kit | Class 2 | 21 CFR 870.1340 | — |
| DQO | MEDLINE CATHETER, INTRAVASCULAR, DIAGNOSTIC - DQOCatheter, Intravascular, Diagnostic | Class 2 | 21 CFR 870.1200 | K120008 |
| OFF | Medline / CDS central venous catheter tray (kit)Central Venous Catheter Tray | Class 2 | 21 CFR 870.1140 | — |
and 89 more on your full dossier
What changed
Nothing added in the last twelve months, and no change seen on the record yet.