FDA UDI
Not in Commercial Distribution
🇺🇸 United States
LabTemp 20
DI: M74460001
·
Model: 6000
·
BIOSYNERGY, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
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Basic Information
- Brand Name
- LabTemp 20
- Primary DI
- M74460001
- Version / Model
- 6000
- Company Name
- BIOSYNERGY, INC.
- Labeler DUNS
- 070698154
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2017-06-01
- Public Version
- 4
- Public Version Date
- 2022-05-12
- Public Version Status
- Update
- Public Device Record Key
- 6d96caf5-6b70-4906-879a-2a4a1ee10261
- Distribution End Date
- 2022-02-12
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| JRR | Regulator, Temperature | 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 |
|---|---|---|---|---|---|---|
| Package | M74460002 | HIBCC | Case | 5 | Not in Commercial Distribution | 2022-02-12 |
| Primary | M74460001 | HIBCC | ||||
| Unit of Use | M74460000 | HIBCC |
Customer Contacts
- Phone
- 800-255-5274
- [email protected]