Identity
- Trade Name
- Axiom® CWV FDA UDI
- Generic Name
- Closed-wound drain, non-bioabsorbable FDA UDI
- Device Name
- Closed Wound Drain, Round, Silicone FDA UDI
- Model / Reference
- 3641 FDA UDI
- Description
- Closed Wound Drain, Round, Silicone FDA UDI
Identifiers
- Primary DI / UDI-DI
- M66536410 FDA UDI
- 510(k) Number
- K790654 FDA UDI
- FDA Product Code
- GCY FDA UDI
- GMDN Term
- Closed-wound drain, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4680 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
Category: Closed-wound drain, non-bioabsorbable
Axiom® CWV by Axiom Medical, Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Closed-wound drain, non-bioabsorbable.
- Argyle — Cardinal Health 200, LLC · Class II
- ReSolve® — Merit Medical Systems, Inc. · Class I
- One-Step™ — Merit Medical Systems, Inc. · Class I
- Argyle — Cardinal Health 200, LLC · Class II
- Silicone Vac Drain, Round — FORTUNE MEDICAL INSTRUMENT CORP. · Class IIa
- SKATER™ Mini-Loop Drainage Set — Argon Medical Devices, Inc. · Class I
- Drainage Tube and Accessories — Hangzhou Fushan Medical Appliances Co., Ltd. · Class IIa
- Exodus — NAVILYST MEDICAL, INC. · Class II
Cleared under the same submission
K790654 also covers:
- Axiom® CWV — AXIOM MEDICAL, INCORPORATED
- Axiom® CWV — AXIOM MEDICAL, INCORPORATED
- Axiom® CWV — AXIOM MEDICAL, INCORPORATED
- Axiom® CWV — AXIOM MEDICAL, INCORPORATED
- Axiom® CWV — AXIOM MEDICAL, INCORPORATED
- Axiom® CWV — AXIOM MEDICAL, INCORPORATED
- Axiom® CWV — AXIOM MEDICAL, INCORPORATED
- Axiom® CWV — AXIOM MEDICAL, INCORPORATED
- Axiom® CWV — AXIOM MEDICAL, INCORPORATED
- Axiom® CWV — AXIOM MEDICAL, INCORPORATED
- Axiom® CWV — AXIOM MEDICAL, 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Axiom Medical, Incorporated
Sources (1)
- FDA UDI 4633e5e0-94de-4d07-af5b-fc10e4398c52 36 fields · synced May 29, 2026