Identity
- Trade Name
- Halyard FDA UDI
- Generic Name
- Wound irrigation sterile water FDA UDI
- Device Name
- IRRIGATION BOTTLE STERILE WATER 100ML PP CLEAR CA/48 STERILE NOT MADE WITH NATURAL RUBBER LATEX HALYARD FDA UDI
- Model / Reference
- 49151 FDA UDI
- Description
- IRRIGATION BOTTLE STERILE WATER 100ML PP CLEAR CA/48 STERILE NOT MADE WITH NATURAL RUBBER LATEX HALYARD FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10885632395901 FDA UDI
- 510(k) Number
- K083042 FDA UDI
- FDA Product Code
- FRO FDA UDI
- GMDN Term
- Wound irrigation sterile water FDA UDI
Classification
- Device Class
- U 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: Wound irrigation sterile water
Halyard by Owens & Minor Distribution, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K083042 also covers:
- Argyle — Cardinalhealth
- Argyle — Cardinalhealth
- Argyle — Cardinalhealth
- Argyle — Cardinalhealth
- Kendall — Cardinalhealth
- Kendall — Cardinalhealth
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL 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 U | Pending data |
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Manufacturer
- Manufacturer
- Owens & Minor Distribution, Inc.
Sources (1)
- FDA UDI 116a6532-4fb4-4c97-8bfb-bc7957f346c2 34 fields · synced May 31, 2026