FDA UDI
In Commercial Distribution
🇺🇸 United States
AllCare, INC
DI: 10182921000912
·
Model: EB100
·
ALLCARE, INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
20
Basic Information
- Brand Name
- AllCare, INC
- Primary DI
- 10182921000912
- Version / Model
- EB100
- Catalog Number
- EB100
- Company Name
- ALLCARE, INC
- Labeler DUNS
- 362187580
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2021-11-20
- Public Version
- 1
- Public Version Date
- 2021-11-29
- Public Version Status
- New
- Public Device Record Key
- 5be99274-3e72-4cf8-8f35-66d0079ddd1b
Device Description
EMERGENCY BARRIER TRAUMA BLANKET YELLOW
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
- Yes
- 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 |
|---|---|---|---|---|
| KME | Bedding, Disposable, Medical | General Hospital | 880.6060 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47447 | Bed blanket, single-use | A large piece of fabric or fabric-like material used to cover a patient/person to insulate body heat for warmth. It is typically used as a bed covering, but may be used for other purposes (e.g., as a wrap for warmth and comfort). This device is intended to be used by one patient for a limited time, without laundering, and then discarded (e.g., incinerated). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10182921000912 | GS1 | ||||
| Unit of Use | 00182921000915 | GS1 |
Customer Contacts
- Phone
- 6308307486
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 30 Degrees Celsius