FDA UDI
In Commercial Distribution
🇺🇸 United States
HALYARD
DI: 10885632460326
·
Model: 61347
·
OWENS & MINOR DISTRIBUTION, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- HALYARD
- Primary DI
- 10885632460326
- Version / Model
- 61347
- Company Name
- OWENS & MINOR DISTRIBUTION, INC.
- Labeler DUNS
- 007941230
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-02-05
- Public Version
- 1
- Public Version Date
- 2026-02-13
- Public Version Status
- New
- Public Device Record Key
- e9c13fd9-dc35-4102-a390-70715a5ed83e
Device Description
HYH No Sting barrier film non woven wipe 1 ml
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NEC | Bandage, liquid, skin protectant | General Hospital | 880.5090 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58978 | Synthetic-polymer liquid barrier dressing | A liquid preparation composed of synthetic polymer materials intended to form a thin protective film when applied to superficial wounds (e.g., minor cuts, abrasions) and/or intact skin (typically sensitive areas such as around a stoma), to reduce exposure to external contaminants; may also be intended to augment the adherence of medical adhesives, or provide a protective interface when removing medical adhesives. It may be presented as a wipe, swab, or spray. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30885632460320 | GS1 | 100 | In Commercial Distribution | ||
| Primary | 10885632460326 | GS1 | ||||
| Package | 20885632460323 | GS1 | 100 | In Commercial Distribution |