FDA UDI
In Commercial Distribution
🇺🇸 United States
REMEL
DI: 00848838090530
·
Model: R31925
·
REMEL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- REMEL
- Primary DI
- 00848838090530
- Version / Model
- R31925
- Catalog Number
- R31925
- Company Name
- REMEL, INC.
- Labeler DUNS
- 065769564
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-22
- Public Version
- 1
- Public Version Date
- 2022-12-30
- Public Version Status
- New
- Public Device Record Key
- d1cae781-342c-4124-838e-937643d00338
Device Description
Cary-Blair Orange w/Ind (15ml Vi) PK/120
Device Characteristics
- Single Use
- No
- 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
- No
- 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 |
|---|---|---|---|---|---|---|
| Primary | 00848838090530 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K013711 | 000 |