FDA UDI
In Commercial Distribution
🇺🇸 United States
CARE SCIENCE
DI: 00017276236804
·
Model: 017276236804
·
Aso LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
20
Basic Information
- Brand Name
- CARE SCIENCE
- Primary DI
- 00017276236804
- Version / Model
- 017276236804
- Company Name
- Aso LLC
- Labeler DUNS
- 152793493
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2020-04-29
- Public Version
- 1
- Public Version Date
- 2020-05-07
- Public Version Status
- New
- Public Device Record Key
- 75cb92cc-df06-443a-a756-f22329e927ed
Device Description
Hydrocolloid Gel Blister Cushions, assorted sizes, 1.6 IN x 2.6 IN (42 mm x 68 mm), 0.7 IN x 2.3 IN (20 mm x 60 mm), 0.6 IN x 2.0 IN (17 mm x 51 mm)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| NAD | Dressing, Wound, Occlusive | General, Plastic Surgery | 878.4020 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62873 | Exudate-absorbent dressing, hydrophilic-gel, non-sterile | A non-sterile adhesive covering intended to assist treatment and protection of fluid-filled superficial lesions (e.g., cold sores, mild acne spots/pimples, opened blisters) and/or minor abrasions by producing a water-absorbent gel upon contact with exudate and maintaining a moist environment; it does not contain an antimicrobial agent. It may be available in various forms (e.g., flat sheet/film, pad) and is typically made of hydrocolloid. It is normally available [non-prescription] over-the-counter (OTC). After application, this device cannot be reused. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20017276236808 | GS1 | Case | 12 | In Commercial Distribution | |
| Primary | 00017276236804 | GS1 | ||||
| Unit of Use | 60017276236806 | GS1 |
Customer Contacts
- Phone
- 1-855-823-4545
- [email protected]