FDA UDI
In Commercial Distribution
🇺🇸 United States
ThermoChem
DI: 00851450007091
·
Model: IPH Table Pack replacement
·
THERMASOLUTIONS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ThermoChem
- Primary DI
- 00851450007091
- Version / Model
- IPH Table Pack replacement
- Catalog Number
- 111-3025
- Company Name
- THERMASOLUTIONS, INC.
- Labeler DUNS
- 186855925
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-11-20
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- a6a2427d-e313-49e8-87fc-1ddbfd0c031b
Device Description
replacement sterile table pack in the event the sterility of the IPH table pack has been compromised.
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 |
|---|---|---|---|---|
| MLW | Warmer, Peritoneal Dialysate | Gastroenterology, Urology | 876.5630 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56634 | Intraperitoneal-circulation hypothermia system administration kit | A collection of sterile devices designed to be used in the function of an automated peritoneal lavage system (APLS). It typically includes tubing to connect the infusion/extraction pump mechanism of the control unit and the other components of the system [also known as the lavage administration set (LAS)], a peritoneal lavage catheter, a heat exchanger, a core body temperature probe (e.g., oesophageal), an infusate temperature sensor, a peritoneal pressure sensor, waste receptacle, and other appropriate devices for this treatment. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00851450007091 | GS1 |
Customer Contacts
- Phone
- 6512093900
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Depth | 4 | Inch | |
| Width | 16 | Inch | |
| Length | 16 | Inch | |
| Weight | 1 | Pound |