Identity
- Trade Name
- Medex FDA UDI
- Generic Name
- Luer/Luer linear connector, single-use FDA UDI
- Model / Reference
- MX20999 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10351688508386 FDA UDI
- 510(k) Number
- K841882 FDA UDI
- FDA Product Code
- FPA FDA UDI
- GMDN Term
- Luer/Luer linear connector, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5440 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
Category: Luer/Luer linear connector, single-use
Medex by Icu Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Luer/Luer linear connector, single-use.
- BD PhaSeal — BECTON DICKINSON PEN LIMITED · Class II
- iLet Insulin Infusion Kit - Inset (23”, 6mm) 15-Pack (Pharmacy Kit) — Beta Bionics, Inc. · Class II
- Cook — COOK INCORPORATED · Class II
- Codan — CODAN US Corporation · Class II
- Bioseal Inc. — BIOSEAL · Class I
- BD Syringe Filling Connector — BECTON DICKINSON AND COMPANY · Class I
- TRUWAVE — Edwards Lifesciences LLC · Class II
- Aspiration and Flush Assembly — Uresil Corp. · Class I
Cleared under the same submission
K841882 also covers:
- Medex — ICU MEDICAL, INC.
- Medex — ICU MEDICAL, INC.
- Medex — ICU MEDICAL, INC.
- Medex — ICU MEDICAL, INC.
- Medex — ICU MEDICAL, INC.
- Medex — ICU MEDICAL, INC.
- Medex — ICU MEDICAL, INC.
- Medex — ICU MEDICAL, INC.
- Medex — ICU MEDICAL, INC.
- Medex — ICU MEDICAL, INC.
- Medex — ICU MEDICAL, INC.
- Medex — ICU MEDICAL, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Icu Medical, Inc.
Sources (1)
- FDA UDI d1fab41f-0269-4496-a245-6f05cdf76b4d 33 fields · synced May 30, 2026