FDA UDI
In Commercial Distribution
🇺🇸 United States
carePAC
DI: 00850003042183
·
Model: ECA-030
·
Extremity Care
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- carePAC
- Primary DI
- 00850003042183
- Version / Model
- ECA-030
- Company Name
- Extremity Care
- Labeler DUNS
- 086365085
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-02-02
- Public Version
- 1
- Public Version Date
- 2023-02-10
- Public Version Status
- New
- Public Device Record Key
- d9ab61c1-2a94-4629-bfe3-7cd174ab88cc
Device Description
Daily carePAC Collagen Powder & Antimicrobial 30PAC
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 |
|---|---|---|---|---|---|---|
| Package | 10850003042180 | GS1 | Box | 30 | In Commercial Distribution | |
| Primary | 00850003042183 | GS1 |
Customer Contacts
- Phone
- 1-888-869-6694
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 25 Degrees Celsius