FDA UDI
In Commercial Distribution
🇺🇸 United States
FecalSwab®
DI: 28053326002209
·
Model: 4C024S10
·
COPAN ITALIA SPA
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
10
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Basic Information
- Brand Name
- FecalSwab®
- Primary DI
- 28053326002209
- Version / Model
- 4C024S10
- Catalog Number
- 4C024S10
- Company Name
- COPAN ITALIA SPA
- Labeler DUNS
- 428981112
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2024-05-07
- Public Version
- 1
- Public Version Date
- 2024-05-15
- Public Version Status
- New
- Public Device Record Key
- 97d7ce13-a1d1-47e1-bb3f-cfd6f15cc434
Device Description
2 ml modified Cary Blair Orange Cap+Flocked Swab
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
- 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 |
| LIO | Device, Specimen Collection | Microbiology | 866.2900 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65197 | Rectal/faecal specimen collection kit | A collection of devices intended exclusively for professional use for the collection, and preservation and/or transport, of a rectal/faecal specimen for subsequent laboratory analysis [e.g., nucleic acid technique (NAT), microbiological culture]. The kit consists of a specimen sampling/collection tool(s) [e.g., swab, spatula], and a covered receptacle with or without an additive/medium (e.g., cell or nucleic acid preservation solution, Carey-Blair transport 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 | 38053326002206 | GS1 | 20 | In Commercial Distribution | ||
| Primary | 28053326002209 | GS1 | ||||
| Unit of Use | 18053326002202 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K142094 | 000 |