FDA UDI
In Commercial Distribution
🇺🇸 United States
CARDINAL HEALTH
DI: 10885380163555
·
Model: C8552-13D
·
CARDINAL HEALTH 200, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- CARDINAL HEALTH
- Primary DI
- 10885380163555
- Version / Model
- C8552-13D
- Catalog Number
- C8552-13D
- Company Name
- CARDINAL HEALTH 200, LLC
- Labeler DUNS
- 112164780
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-12-18
- Public Version
- 6
- Public Version Date
- 2022-04-08
- Public Version Status
- Update
- Public Device Record Key
- effebf2f-19a7-412b-90d7-39bde132c13a
Device Description
Collection and Transport Swab Microorganism Collection and Transport System
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- Sterilization Methods
- Radiation Sterilization
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 | 20885380163552 | GS1 | PACK | 50 | In Commercial Distribution | |
| Primary | 10885380163555 | GS1 | ||||
| Package | 50885380163553 | GS1 | CASE | 10 | In Commercial Distribution |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 25 Degrees Celsius