Identity
- Trade Name
- Halyard FDA UDI
- Generic Name
- Non-antimicrobial wound irrigation solution, saline FDA UDI
- Device Name
- IRRIGATION BOTTLE SODIUM CHLORIDE .9P 1000ml PP CLEAR CA/6 STERILE NOT MADE WITH NATUAL RUBBER LATEX HALYARD FDA UDI
- Model / Reference
- 49154 FDA UDI
- Description
- IRRIGATION BOTTLE SODIUM CHLORIDE .9P 1000ml PP CLEAR CA/6 STERILE NOT MADE WITH NATUAL RUBBER LATEX HALYARD FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10885632395932 FDA UDI
- 510(k) Number
- K083042 FDA UDI
- FDA Product Code
- FRO FDA UDI
- GMDN Term
- Non-antimicrobial wound irrigation solution, saline 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Non-antimicrobial wound irrigation solution, saline
Halyard by Owens & Minor Distribution, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Non-antimicrobial wound irrigation solution, saline.
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- SteriCare Solutions — NURSE ASSIST, INC. · U
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- SteriCare Solutions — NURSE ASSIST, INC. · U
- Premier Solution Saline Wound Wash — Premier Brands of America, Inc. · Class II
- NeilMed Wound Wash — NeilMed Pharmaceuticals Inc. · U
- SteriCare Solutions — NURSE ASSIST, INC. · U
- Caring Mill Saline Wound Wash — Caring Mill · Class II
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 864fe7dc-c2cd-40d9-9f0c-87fafdcb3b1f 34 fields · synced May 30, 2026