FDA UDI
In Commercial Distribution
🇺🇸 United States
MicroTest M4RT
DI: 00842558110202
·
Model: R12901
·
Remel Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MicroTest M4RT
- Primary DI
- 00842558110202
- Version / Model
- R12901
- Catalog Number
- R12901
- Company Name
- Remel Inc.
- Labeler DUNS
- 118161628
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-01-05
- Public Version
- 1
- Public Version Date
- 2023-01-13
- Public Version Status
- New
- Public Device Record Key
- 718a082c-2a94-4a4c-b58d-8cb77d16c48c
Device Description
M4RT(3ml) 2NPG Swab KIT
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
- 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 |
|---|---|---|---|---|
| JSM | Culture Media, Non-Propagating Transport | Microbiology | 866.2390 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66118 | Microbiological transport medium IVD | A medium in powder, liquid, broth or gel form, commonly available in a tub or bottle from which aliquots can be prepared, intended to be used to maintain the viability of microorganisms suspected of being present in a clinical specimen during its transport prior to in vitro diagnostic analysis and/or culture. It has a non-nutritive composition with or without indicator and may include types such as Amies, anaerobic, Carey-Blair, Stuart, and viral transport/inactivation mediums. This device is not a specimen collection tube/container (i.e., is not intended to directly accept a specimen), and does not include patient-contact specimen sampling/extraction devices such as swabs/brushes. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00842558110202 | GS1 |