FDA UDI
In Commercial Distribution
🇺🇸 United States
LBM® UriSponge™
DI: 18053326003742
·
Model: 8C023S01.A
·
COPAN ITALIA SPA
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
Basic Information
- Brand Name
- LBM® UriSponge™
- Primary DI
- 18053326003742
- Version / Model
- 8C023S01.A
- Catalog Number
- 8C023S01.A
- Company Name
- COPAN ITALIA SPA
- Labeler DUNS
- 428981112
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2022-12-07
- Public Version
- 2
- Public Version Date
- 2023-08-03
- Public Version Status
- Update
- Public Device Record Key
- 28006d68-8b4e-4a08-ae29-389e656eef81
Device Description
UriSponge™ – Urine Collection, Transport and Preservation System Mini size - in single pouch
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 |
|---|---|---|---|---|
| 63348 | Non-evacuated urine specimen container IVD, preservative | A covered receptacle containing one or multiple preservatives [e.g., mercuric oxide, boric acid (H3BO3), benzoic acid, potassium phosphate, and/or sodium phosphate] intended to be used for the collection, preservation, and/or transport, of a urine specimen for culture, analysis, and/or other in vitro diagnostic investigation. It may include a disposable pipette to transfer the urine specimen into a secondary container (not included). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 28053326003749 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 18053326003742 | GS1 | ||||
| Unit of Use | 08053326003745 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K180052 | 000 |