FDA UDI
In Commercial Distribution
🇺🇸 United States
IH-Incubator L
DI: 07611969226344
·
Model: 009303
·
Bio-Rad Medical Diagnostics GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- IH-Incubator L
- Primary DI
- 07611969226344
- Version / Model
- 009303
- Company Name
- Bio-Rad Medical Diagnostics GmbH
- Labeler DUNS
- 312576506
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-04-05
- Public Version
- 4
- Public Version Date
- 2022-03-14
- Public Version Status
- Update
- Public Device Record Key
- d45964ed-0ed3-433f-97da-41d953954ac5
Device Characteristics
- Single Use
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| PBC | Manual Blood Grouping And Antibody Test Systems | Hematology | 864.9175 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46944 | Test tube heater | An electrically-powered device used in the laboratory to hold and maintain at specific temperatures test tubes containing a fluid specimen (e.g., cell samples). The device typically contains several slots to hold test tubes upright, and its heating element is controlled electronically to reliably maintain a physiological temperature. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07611969226344 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| BK170066 | 0 |