FDA UDI
In Commercial Distribution
🇺🇸 United States
Sigma Transwab
DI: 05060259073564
·
Model: Amies
·
MEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
125
Basic Information
- Brand Name
- Sigma Transwab
- Primary DI
- 05060259073564
- Version / Model
- Amies
- Catalog Number
- MW176SE23ML
- Company Name
- MEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITED
- Labeler DUNS
- 216096750
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 125
- Record Status
- Published
- Publish Date
- 2023-10-05
- Public Version
- 1
- Public Version Date
- 2023-10-13
- Public Version Status
- New
- Public Device Record Key
- d9867fc9-9bf7-4e18-a729-868b169cfd43
Device Description
Sigma Transwab, 1 x mini & 1 std, 3ml liquid amies
Device Characteristics
- Single Use
- Yes
- 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
- 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 |
|---|---|---|---|---|
| LIO | Device, Specimen Collection | Microbiology | 866.2900 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62773 | General specimen collection kit IVD, clinical | A collection of in vitro diagnostic devices intended exclusively for professional use 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), histopathology]. The kit consists of a specimen sampling/collection tool(s) [e.g., swab, brush, spatula], and a covered specimen receptacle with or without an additive/medium (e.g., preservation solution, microbiological medium). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 25060259073568 | GS1 | ||||
| Primary | 05060259073564 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 25 Degrees Celsius