FDA UDI
In Commercial Distribution
🇺🇸 United States
ThermoSuit System
DI: 10851936007079
·
Model: Disposable Kit, Case
·
LIFE RECOVERY SYSTEMS HD LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
2
Basic Information
- Brand Name
- ThermoSuit System
- Primary DI
- 10851936007079
- Version / Model
- Disposable Kit, Case
- Catalog Number
- 72004
- Company Name
- LIFE RECOVERY SYSTEMS HD LLC
- Labeler DUNS
- 825390458
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2016-09-08
- Public Version
- 4
- Public Version Date
- 2023-12-18
- Public Version Status
- Update
- Public Device Record Key
- abf819a8-68d8-4d21-9133-246e9bda34a2
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
- No
- 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 |
|---|---|---|---|---|
| 36172 | External circulating-fluid core temperature regulation system control unit, cooling-only | An electrically-powered device intended to be used as part of an external circulating-fluid core temperature regulation system to control/regulate the temperature and flow of fluid through a connected patient-applied pad (not included), to lower a patient’s core body temperature. The device includes a refrigeration unit, a pump, and typically a fluid reservoir; it may also be intended for patient temperature monitoring. It is intended to be used by a healthcare professional in a clinical setting typically to treat patients who are hyperthermic/feverish or to induce hypothermia for metabolism reduction (e.g., during surgery). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10851936007079 | GS1 | ||||
| Unit of Use | 00851936007100 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K061023 | 000 |