FDA UDI
In Commercial Distribution
🇺🇸 United States
FORWARD HEAT - Emergency Blanket
DI: 00850056748483
·
Model: FH-EB
·
INTEGRATED MEDCRAFT LLC
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- FORWARD HEAT - Emergency Blanket
- Primary DI
- 00850056748483
- Version / Model
- FH-EB
- Company Name
- INTEGRATED MEDCRAFT LLC
- Labeler DUNS
- 107523667
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-09-02
- Public Version
- 1
- Public Version Date
- 2025-09-10
- Public Version Status
- New
- Public Device Record Key
- 9bcb4a7e-ed11-4e2b-8d00-e923dae9d107
Device Description
A convenience kit for hypothermia management of an injured person, containing the FORWARD APLS Emergency Blanket and Ready-Heat II Torso Sized Quick Warming Blanket. Each kit is contained until usage in an individually packed, waterproof bag to protect its contents from damage and possible contamination.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| KME | Bedding, Disposable, Medical | General Hospital | 880.6060 | 1 |
| IMD | Pack, Hot Or Cold, Disposable | Physical Medicine | 890.5710 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58416 | Activated-medium surgical warming blanket | A non-sterile device intended to help prevent a patient from cooling prior to, during, and after a surgical intervention by serving as a heat-generating cover. It is a highly hygienic device made of plastic material and designed with integrated pockets that hold air-activated warming pads containing various media [e.g., active coal, clay, or salt and iron (Fe) powder] that chemically generate heat when the device is removed from its sealed packaging. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850056748483 | GS1 |