FDA UDI
In Commercial Distribution
🇺🇸 United States
Yellow Emergency Highway Blanket
DI: 00616784351919
·
Model: 3519
·
DYNAREX CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Yellow Emergency Highway Blanket
- Primary DI
- 00616784351919
- Version / Model
- 3519
- Company Name
- DYNAREX CORPORATION
- Labeler DUNS
- 008124539
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-09-01
- Public Version
- 2
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- a7343b6c-06f1-46ef-8a02-c5d7739de846
Device Description
Yellow Emergency Highway Blanket, Economy, 54"x80"
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Safe
- 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 |
|---|---|---|---|---|
| KME | Bedding, Disposable, Medical | General Hospital | 880.6060 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 10416 | Rescue blanket, reusable | A large sheet of material specially designed to keep a person warm and to prevent the further loss of body heat in an emergency rescue situation. It is typically used by emergency medical services (EMS) and typically includes a heat-reflecting metal surface [e.g., aluminium (Al)] to help retain body heat. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00616784351933 | GS1 | Case | 50 | In Commercial Distribution | |
| Primary | 00616784351919 | GS1 |