FDA UDI
Not in Commercial Distribution
🇺🇸 United States
REMEL
DI: 00848838000195
·
Model: R01061
·
REMEL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- REMEL
- Primary DI
- 00848838000195
- Version / Model
- R01061
- Catalog Number
- R01061
- Company Name
- REMEL, INC.
- Labeler DUNS
- 065769564
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-22
- Public Version
- 2
- Public Version Date
- 2023-08-22
- Public Version Status
- Update
- Public Device Record Key
- f1266f4d-5188-4c7a-b39a-020e04deb32d
- Distribution End Date
- 2023-05-10
Device Description
Anaer Reducible Blood Agar 15/PK
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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JSH | Culture Media, Non-Selective And Differential | Microbiology | 866.2320 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61686 | Anaerobic-microorganism antimicrobial susceptibility culture medium IVD | A non-selective culture medium intended to be used to perform diagnostic antimicrobial susceptibility testing of anaerobic microorganisms isolated from a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00848838000195 | GS1 |