FDA UDI
In Commercial Distribution
🇺🇸 United States
Comfort Pack
DI: 00749915002517
·
Model: 110-01
·
AMERICAN SURGICAL COMPANY, LLC
Product Codes
0
GMDN Terms
1
Identifiers
2
Pkg Device Count
30
Basic Information
- Brand Name
- Comfort Pack
- Primary DI
- 00749915002517
- Version / Model
- 110-01
- Company Name
- AMERICAN SURGICAL COMPANY, LLC
- Labeler DUNS
- 151054954
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 30
- Record Status
- Published
- Publish Date
- 2018-01-17
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 27ef54bc-77ad-4278-b3b7-c4e70ddb7f21
Device Description
Comfort Pack
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- 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
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11028 | Cotton ball | A device designed as an absorbent, non-sterile spherical mass of cotton or man-made fibres used as a swab to apply medications to or remove fluid/liquid from various parts of the body. It is used within the healthcare sector or the home and is normally available [non-prescription] over-the-counter (OTC). This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00749915002517 | GS1 | ||||
| Unit of Use | 00749915002500 | GS1 |