FDA UDI
In Commercial Distribution
🇺🇸 United States
TintoRetriever Slide Thermometers
DI: B502BSB70050
·
Model: BSB 7005
·
BIO SB, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- TintoRetriever Slide Thermometers
- Primary DI
- B502BSB70050
- Version / Model
- BSB 7005
- Catalog Number
- BSB 7005
- 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
- ed1e7a6a-067f-438e-8815-fbfd8ff6c8c6
Device Description
TintoRetriever Slide Thermometers are intended as a quality control tool to evaluate the temperature of Retrieval solutions, such as the Bio SB ImmunoDNA Retriever Citrate (BSB 0020 - BSB 0023) and EDTA (BSB 0030 - BSB 0033)
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 |
|---|---|---|---|---|
| 17436 | Laboratory thermometer | An electronic measuring instrument used in the laboratory to measure and establish the level of a temperature in an object, matter, or medium. It is designed for use in the laboratory for temperatures over a wide or particular range. It will have a high degree of accuracy and typically use a thermistor sensor for uptake of the measurement. It is typically used to verify that: 1) devices, e.g., water baths, heated cells or refrigerators, operate within the prescribed temperature limits; and 2) material, e.g., liquids, gases or semi-solids, have reached a desired temperature. For devices intended to measure the body temperature of patients see the appropriate GMDN code. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B502BSB70050 | HIBCC |
Customer Contacts
- Phone
- +1(800)561-1145
- [email protected]