FDA UDI
In Commercial Distribution
🇺🇸 United States
TintoRetriever Digital Pressure Cooker Bundle
DI: B502BSB70150
·
Model: BSB 7015
·
BIO SB, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- TintoRetriever Digital Pressure Cooker Bundle
- Primary DI
- B502BSB70150
- Version / Model
- BSB 7015
- Catalog Number
- BSB 7015
- Company Name
- BIO SB, INC.
- Labeler DUNS
- 102855447
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-18
- Public Version
- 1
- Public Version Date
- 2025-03-26
- Public Version Status
- New
- Public Device Record Key
- 350638e7-1e2e-436a-84c7-a5d4290ea419
Device Description
The TintoRetriever Digital Pressure Cooker is a precision-controlled heat source capable of mantaining a constant and reliable temperature while minimizing the potential for evaporation of the working solution.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| LXG | EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE | Clinical Chemistry | 862.2050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66288 | Pressurized incubator IVD | An electrically-powered pressurized heating chamber intended to be used for the incubation of laboratory specimens for subsequent in vitro diagnostic procedures [e.g., heat-induced epitope retrieval (HIER) and deparaffinization for immunohistochemistry]. It is typically in the form of a pot, similar to a pressure cooker, with a lid and a removable inner liner, where samples are placed in a holder or tray for heating. It is programmable with dedicated software to control settings for temperature, pressure, and incubation time. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B502BSB70150 | HIBCC |
Customer Contacts
- Phone
- +1(800)561-1145
- [email protected]