FDA UDI
In Commercial Distribution
🇺🇸 United States
McKesson
DI: 00612479226951
·
Model: 176-5728
·
MCKESSON MEDICAL-SURGICAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
25
Basic Information
- Brand Name
- McKesson
- Primary DI
- 00612479226951
- Version / Model
- 176-5728
- Company Name
- MCKESSON MEDICAL-SURGICAL INC.
- Labeler DUNS
- 023904428
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2019-04-04
- Public Version
- 1
- Public Version Date
- 2019-04-12
- Public Version Status
- New
- Public Device Record Key
- b6b3aa93-8832-42a8-98e1-aa88e82f0bf2
Device Description
Skin Barrier Film 2.4 in x 2.4 in
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
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| 62524 | Ostomy leak absorbent pad | A non-sterile absorbent device intended to be fitted around the connection between an ostomy base plate and an ostomy bag, to absorb any sweat or bodily fluid/waste associated with a leak between the base plate and the skin, to prevent its spread, absorption by clothing, and to reduce skin irritation. It is a flat pad made from a suitably absorbent material with a hole for installation. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00612479228283 | GS1 | Case | 100 | In Commercial Distribution | |
| Primary | 00612479226951 | GS1 | ||||
| Unit of Use | 00612479240216 | GS1 |