FDA UDI
In Commercial Distribution
🇺🇸 United States
HEALTHCARE CONNECTIONS
DI: 00840216114876
·
Model: HCC KT-OPE-H
·
Asp Global, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HEALTHCARE CONNECTIONS
- Primary DI
- 00840216114876
- Version / Model
- HCC KT-OPE-H
- Company Name
- Asp Global, LLC
- Labeler DUNS
- 080361159
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-08-23
- Public Version
- 1
- Public Version Date
- 2022-08-31
- Public Version Status
- New
- Public Device Record Key
- c6b2fb5b-5e3f-49af-aed0-6eb8c8c8463b
Device Description
UNIVERSAL CPM PAD KIT, BEIGE 1/EA, 10/CS
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- 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
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FMP | Protector, Skin Pressure | General Hospital | 880.6450 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41571 | Custom-made cushion | A soft pillow or pad that is specially designed for an individual to provide support, comfort, or assist the user to fulfill a functional requirement. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840216114876 | GS1 |