FDA UDI
In Commercial Distribution
🇺🇸 United States
Starswab II Bacteriology Culture Collection and Transport System
DI: 00840165400181
·
Model: SP131D
·
Pretium Canada Packaging ULC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
Basic Information
- Brand Name
- Starswab II Bacteriology Culture Collection and Transport System
- Primary DI
- 00840165400181
- Version / Model
- SP131D
- Company Name
- Pretium Canada Packaging ULC
- Labeler DUNS
- 246665038
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2025-02-19
- Public Version
- 1
- Public Version Date
- 2025-02-27
- Public Version Status
- New
- Public Device Record Key
- 6b82c6f1-98ed-41f1-a4c2-a80989036fb3
Device Description
Starswab II Bacteriology Culture Collection and Transport System with Amies Charcoal Gel and double plastic shaft rayon tip swab applicators.
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
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- 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 |
|---|---|---|---|---|---|---|
| Package | 00840165400198 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 00840165400181 | GS1 | ||||
| Unit of Use | 10840165400188 | GS1 |