FDA UDI
In Commercial Distribution
🇺🇸 United States
Fluoroo-Check Heating Block
DI: 00895160002649
·
Model: Heating Block
·
NANO-DITECH CORPORATION
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Fluoroo-Check Heating Block
- Primary DI
- 00895160002649
- Version / Model
- Heating Block
- Catalog Number
- HB101
- Company Name
- NANO-DITECH CORPORATION
- Labeler DUNS
- 126544316
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-02-20
- Public Version
- 5
- Public Version Date
- 2023-06-29
- Public Version Status
- Update
- Public Device Record Key
- ca6ac494-de60-4da8-b797-0a4af732a0b2
Device Description
The Fluoro-Check TM Heating Block is an anti-temperature preservation device designed to obtain optimal temperature from reagents. The compact Digital-controlled Heating Block provides excellent space utilization and superior product quality.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 15105 | Heating block IVD | An electrically-powered device which is primarily a heating element, with or without a thermostat, that is built into a compact block and intended to be used as a stable dry heat source to heat in vitro diagnostic specimens/laboratory materials. It is typically a stand-alone instrument, or an interchangeable component of an in vitro diagnostic instrument/analyser. It is available in various sizes to accommodate microplates of varying sizes, and may include covers to minimize evaporation from microplates. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00895160002649 | GS1 |
Customer Contacts
- Phone
- 1-609-409-3300
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 15 – 35 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 50 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 10 – 80 Percent (%) Relative Humidity