FDA UDI
In Commercial Distribution
🇺🇸 United States
Hypothermia Management Set
DI: M68959120000
·
Model: 00
·
Safeguard US Operating, LLC
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Hypothermia Management Set
- Primary DI
- M68959120000
- Version / Model
- 00
- Catalog Number
- 59-120
- Company Name
- Safeguard US Operating, LLC
- Labeler DUNS
- 118492643
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-04-04
- Public Version
- 2
- Public Version Date
- 2022-04-12
- Public Version Status
- Update
- Public Device Record Key
- b78a6d56-7714-4d43-824d-9c217366a62b
Device Description
HYPOTHERMIA MANAGEMENT SET 1 ea - 7.5" x 6.5" Blizzard Light Blanket, 1 ea - 34" x 48" Ready-Heat warming blanket WARNING: Do not place Ready-Heat on exposed skin.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- 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
- 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 |
|---|---|---|---|---|
| IMD | Pack, Hot Or Cold, Disposable | Physical Medicine | 890.5710 | 1 |
| KME | Bedding, Disposable, Medical | General Hospital | 880.6060 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62340 | Hypothermia-prevention whole-body suit | A full-body overall intended to be worn by a patient in a clinical setting to minimize loss of body heat when the patient experiences low body temperature and/or is under at-risk conditions for low body temperature (e.g., long surgical procedures). It is typically a multilayer or multi-laminate suit made of synthetic materials including a layer with heat-insulating properties to facilitate retention of body heat. This is a reusable device after appropriate cleaning. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M68959120000 | HIBCC |