FDA UDI
In Commercial Distribution
🇺🇸 United States
carePAC
DI: 00850003042404
·
Model: CS-PA01
·
Extremity Care
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- carePAC
- Primary DI
- 00850003042404
- Version / Model
- CS-PA01
- Company Name
- Extremity Care
- Labeler DUNS
- 086365085
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-02-06
- Public Version
- 1
- Public Version Date
- 2024-02-14
- Public Version Status
- New
- Public Device Record Key
- 8b1f2009-70ee-4ba2-9d92-79c535dff6af
Device Description
carePAC Standard Size, Collagen Powder w/ Antimicrobial Gauze Kit includes: CP001 - 1 g Collagen Powder with Primary DI: 4052199578750 or 00366977311014 CP004 - AMD Antimicrobial Gauze with Primary DI: 4052199576503 CP009 - Conforming Stretch Bandage 4inx4.1yds with Primary DI: 10612553016222 or 10612553013221 CP000 - Gloves
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MCY | Wound Dressing Kit | General Hospital | 880.5075 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34059 | Wound dressing kit, medicated | A collection of instruments, dressings, and pharmaceuticals intended to be used to dress a wound. Items typically include scissors, forceps, gauze, cotton-tip applicators, and antiseptics. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850003042404 | GS1 | ||||
| Package | 10850003042401 | GS1 | Box | 30 | In Commercial Distribution |
Customer Contacts
- Phone
- 18886946694
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 25 Degrees Celsius