Identity
- Trade Name
- MEDLINE FDA UDI
- Generic Name
- Central venous catheterization kit, short-term FDA UDI
- Device Name
- CVC TRIPLE LUMEN BUNDLE FDA UDI
- Model / Reference
- ECVC1375 FDA UDI
- Description
- CVC TRIPLE LUMEN BUNDLE FDA UDI
Identifiers
- Catalog Number
- ECVC1375 FDA UDI
- Primary DI / UDI-DI
- 10653160383741 FDA UDI
- 510(k) Number
- K213481 FDA UDI
- FDA Product Code
- LRO FDA UDI
- GMDN Term
- Central venous catheterization kit, short-term FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4370 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
Yes
FDA UDI
Combination Product
Yes
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
Category: Central venous catheterization kit, short-term
Medline by Medline Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Central venous catheterization kit, short-term.
- Acent-1 — Global Medikit Limited · Class III
- Centurion — Centurion Medical Products · Class II
- Cook — COOK INCORPORATED · Class II
- Shun Monitor® — Shunmei Medical Co.,Ltd · Class III
- ARROW — TELEFLEX INCORPORATED · Class II
- Medline Industries, Inc. — Centurion Medical Products · Class II
- Arrowg+ard Blue(R) Five-Lumen CVC — Arrow International LLC (Subsidiary of Teleflex Incorporated) · Class III
- ARROW — TELEFLEX INCORPORATED · Class II
Cleared under the same submission
K213481 also covers:
- Centurion — Centurion Medical Products
- Centurion — Centurion Medical Products
- Centurion — Centurion Medical Products
- Centurion — Centurion Medical Products
- Centurion — Centurion Medical Products
- Centurion — Centurion Medical Products
- Centurion — Centurion Medical Products
- Centurion — Centurion Medical Products
- Centurion — Centurion Medical Products
- Centurion — Centurion Medical Products
- Centurion — Centurion Medical Products
- Centurion — Centurion Medical Products
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
- Medline Industries, Inc.
Sources (1)
- FDA UDI 94564d06-20af-48ce-9e26-3eb7cc916d50 36 fields · synced Jun 8, 2026