FDA UDI
In Commercial Distribution
🇺🇸 United States
Fisherbrand
DI: 00613647008768
·
Model: 1490724
·
FISHER SCIENTIFIC COMPANY L.L.C.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
50
Basic Information
- Brand Name
- Fisherbrand
- Primary DI
- 00613647008768
- Version / Model
- 1490724
- Catalog Number
- 1490724
- Company Name
- FISHER SCIENTIFIC COMPANY L.L.C.
- Labeler DUNS
- 004321519
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2022-11-29
- Public Version
- 1
- Public Version Date
- 2022-12-07
- Public Version Status
- New
- Public Device Record Key
- da832e32-212a-497a-847a-7b436c16c6cd
Device Description
SWAB LIQ AMIES DBL FB 50/PK
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| 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 | 30613647008769 | GS1 | CASE | 10 | In Commercial Distribution | |
| Package | 20613647008762 | GS1 | PACK | 1 | In Commercial Distribution | |
| Primary | 00613647008768 | GS1 | ||||
| Unit of Use | 10613647008765 | GS1 |
Customer Contacts
- Phone
- +1(724)517-2425
- [email protected]