FDA UDI
In Commercial Distribution
🇺🇸 United States
Mawi DNA Technologies
DI: 00850040712124
·
Model: ISM-T-1200
·
Mawi Dna Technologies, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Mawi DNA Technologies
- Primary DI
- 00850040712124
- Version / Model
- ISM-T-1200
- Catalog Number
- ISM-T-1200
- Company Name
- Mawi Dna Technologies, LLC
- Labeler DUNS
- 005460723
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-04-06
- Public Version
- 1
- Public Version Date
- 2022-04-14
- Public Version Status
- New
- Public Device Record Key
- 6397d1c4-3635-4eb0-9128-7641b1142bd6
Device Description
iSWAB Microbiome Collection Tube 1.0 ml
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| PPM | General Purpose Reagent | Pathology | 864.4010 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63232 | General specimen container IVD, additive/medium | A covered receptacle containing an additive and/or medium [e.g., preservative solution, microbiological medium (e.g., Amies, Stuart, anaerobic, viral transport/inactivation medium)] intended to be used for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, vaginal secretions) derived from different body regions for in vitro diagnostic investigation [e.g., nucleic acid technique (NAT), microbiological culture, histopathology]. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10850040712121 | GS1 | Rack | 50 | In Commercial Distribution | |
| Primary | 00850040712124 | GS1 | ||||
| Package | 20850040712128 | GS1 | Bag | 500 | In Commercial Distribution |
Customer Contacts
- Phone
- 510-256-5186
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius