Identity
- Trade Name
- One-Lumen CVC EUDAMEDARROW FDA UDI
- Generic Name
- Central venous catheterization kit, short-term FDA UDI
- Device Name
- Central Venous Catheter (CVC) Product EUDAMEDOne-Lumen CVC FDA UDI
- Model / Reference
- AK-04660-S EUDAMEDIPN918849 FDA UDI
- Description
- One-Lumen CVC FDA UDI
Identifiers
- Catalog Number
- AK-04660-S FDA UDI
- Primary DI / UDI-DI
- 10801902184556 EUDAMEDFDA UDI
- Basic UDI-DI
- 08019020000000000000042K8 EUDAMED
- 510(k) Number
- K810962 FDA UDI
- FDA Product Code
- DQY FDA UDI
- EMDN Code
- C01020201 CENTRAL I.V. SINGLE-LUMEN CATHETERS, NON-TUNNELED EUDAMED
- GMDN Term
- Central venous catheterization kit, short-term FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1250 FDA UDI
- Medical Purpose
- The Arrow catheter is indicated to permit short-term (< 30 day) central venous access for the treatment of diseases or conditions requiring central venous access, including, but not limited to the following: Lack of usable peripheral IV sites Central venous pressure monitoring Total parenteral nutrition (TPN) Infusions of fluids, medications, or chemotherapy Frequent blood sampling or receiving blood transfusions/blood products Injection of contrast media When used for pressure injection of contrast media, do not exceed the maximum indicated flow rate for each catheter lumen. The maximum pressure of power injector equipment used with the pressure injectable CVC may not exceed 400 psi. EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA 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
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
Yes
FDA UDI
Category: Central venous catheterization kit, short-term
Arrow by Teleflex Incorporated — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — 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
K810962 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 (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Teleflex Incorporated
Sources (2)
- FDA UDI 042ab076-6c9c-4fcb-98d8-7796f3f62278 36 fields · synced Jun 19, 2026
- EUDAMED 20427fea-4102-4846-9c40-596fafb3d5e7 61 fields · synced Jun 19, 2026