Identity
- Trade Name
- ARROW FDA UDI
- Generic Name
- Central venous catheterization kit, short-term FDA UDI
- Device Name
- Pressure Injectable Arrowg+ard Blue Advance(R) Two-Lumen JACC Kit FDA UDI
- Model / Reference
- IPN928552 FDA UDI
- Description
- Pressure Injectable Arrowg+ard Blue Advance(R) Two-Lumen JACC Kit FDA UDI
Identifiers
- Catalog Number
- ASK-41552-LTAC FDA UDI
- Primary DI / UDI-DI
- 10801902216325 FDA UDI
- 510(k) Number
- K132133 FDA UDI
- FDA Product Code
- LJS FDA UDI
- GMDN Term
- Central venous catheterization kit, short-term FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5970 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
Arrow by Teleflex Incorporated — 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
- MEDLINE — MEDLINE INDUSTRIES, INC. · Class II
- Cook — COOK INCORPORATED · Class II
- Shun Monitor® — Shunmei Medical Co.,Ltd · Class III
- Medline Industries, Inc. — Centurion Medical Products · Class II
- MEDLINE — MEDLINE INDUSTRIES, INC. · Class II
- Arrowg+ard Blue(R) Five-Lumen CVC — Arrow International LLC (Subsidiary of Teleflex Incorporated) · Class III
Cleared under the same submission
K132133 also covers:
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
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 |
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Manufacturer
- Manufacturer
- Teleflex Incorporated
Sources (1)
- FDA UDI 56a7fc0b-a56b-4ec0-879e-9da0a05e8263 37 fields · synced May 31, 2026