FDA UDI
In Commercial Distribution
🇺🇸 United States
Colibrí™ Primary Tube with Water
DI: 18050148217975
·
Model: WR090-01-0003
·
COPAN WASP SRL
Product Codes
3
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
Basic Information
- Brand Name
- Colibrí™ Primary Tube with Water
- Primary DI
- 18050148217975
- Version / Model
- WR090-01-0003
- Catalog Number
- WR090-01-0003
- Company Name
- COPAN WASP SRL
- Labeler DUNS
- 434263590
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2024-01-31
- Public Version
- 1
- Public Version Date
- 2024-02-08
- Public Version Status
- New
- Public Device Record Key
- 82a2f4b5-5b7d-4011-b0a1-0e292b4057e2
Device Description
Colibrí™ Primary Tube with Water
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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QBN | Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates | Microbiology | 866.3378 | 2 |
| QQV | Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry | Microbiology | 866.3378 | 2 |
| LON | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation | Microbiology | 866.1645 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42651 | Buffered isotonic saline reagent IVD | A buffered isotonic saline solution intended to be used alone or in combination with other IVDs in the processing, staining, and/or testing of clinical laboratory specimens. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 58050148217973 | GS1 | ||||
| Primary | 18050148217975 | GS1 |
Customer Contacts
- Phone
- +390302687218
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K232756 | 000 |