FDA UDI
In Commercial Distribution
🇺🇸 United States
ThermoSuit System
DI: 00851936007126
·
Model: Activation Kit
·
LIFE RECOVERY SYSTEMS HD LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ThermoSuit System
- Primary DI
- 00851936007126
- Version / Model
- Activation Kit
- Catalog Number
- 76003
- Company Name
- LIFE RECOVERY SYSTEMS HD LLC
- Labeler DUNS
- 825390458
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-03-03
- Public Version
- 1
- Public Version Date
- 2020-03-11
- Public Version Status
- New
- Public Device Record Key
- e5fd1cb4-d846-4083-ac54-dac3843ce6a9
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- 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 |
|---|---|---|---|---|
| NZE | Hyperthermia Monitor | Cardiovascular | 870.5900 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37147 | Cooling utility supply system | An assembly of devices designed to provide utilities/amenities (e.g., water, compressed air) to cool other medical devices, data equipment, or laboratory devices/equipment to facilitate their operation. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00851936007126 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K061023 | 000 |