FDA UDI
In Commercial Distribution
🇺🇸 United States
HypothermX HX100 Intravenous Fluid and Blood Warmer
DI: 00850003277004
·
Model: FA100001
·
EMIT CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
6
Pkg Device Count
1
Basic Information
- Brand Name
- HypothermX HX100 Intravenous Fluid and Blood Warmer
- Primary DI
- 00850003277004
- Version / Model
- FA100001
- Company Name
- EMIT CORPORATION
- Labeler DUNS
- 958227451
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-10-25
- Public Version
- 2
- Public Version Date
- 2022-03-22
- Public Version Status
- Update
- Public Device Record Key
- fff3fa36-7042-4522-8656-128908421599
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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LGZ | Warmer, Thermal, Infusion Fluid | General Hospital | 880.5725 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47616 | Conduction blood/fluid warmer | An electrically-powered device designed for in-line heating of banked blood, blood products, intravenous (IV) solutions, and irrigation fluids, typically from about 4ºC to near body temperature (i.e., 35 to 37ºC) before infusion, through the conduction of heat. The device usually includes a surface heat exchanger (e.g., heated dry plate) for the conduction of heat to the infusion blood/fluid via a disposable set (e.g., tubing or pouch); it also includes temperature controls and/or alarms. It is typically mounted on an IV pole under the infusion bag; it does not infuse blood/fluid. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00850003277035 | GS1 | 2 Pack | 2 | In Commercial Distribution | |
| Primary | 00850003277004 | GS1 | ||||
| Package | 00850003277011 | GS1 | 5 Pack | 5 | In Commercial Distribution | |
| Package | 00850003277028 | GS1 | Single Pack | 1 | In Commercial Distribution | |
| Package | 00850003277110 | GS1 | 4 Pack | 4 | In Commercial Distribution | |
| Package | 00850003277103 | GS1 | 3 Pack | 3 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K103801 | 000 |