FDA UDI
Not in Commercial Distribution
🇺🇸 United States
CARDINAL HEALTH
DI: 10885380151255
·
Model: CA11825
·
Aero-Med, Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- CARDINAL HEALTH
- Primary DI
- 10885380151255
- Version / Model
- CA11825
- Catalog Number
- CA11825
- Company Name
- Aero-Med, Ltd.
- Labeler DUNS
- 194550042
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-04-25
- Public Version
- 5
- Public Version Date
- 2023-02-01
- Public Version Status
- Update
- Public Device Record Key
- 234bf82f-1fe7-4fae-a570-9ac9c63cd0b6
- Distribution End Date
- 2023-02-01
Device Description
Fecal Collection and Transport Kit, Memorial Hospital of Union County
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| OIB | Blood and urine collection kit (excludes HIV testing) | Pathology | 864.3250 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57911 | Faecal specimen container IVD, transport buffer/medium | A covered receptacle containing transport buffer solution or microbiological medium (e.g., Carey-Blair transport medium) intended to be used for the collection, preservation, and transport of a faecal specimen for in vitro diagnostic investigation. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50885380151253 | GS1 | CASE | 25 | Not in Commercial Distribution | 2023-02-01 |
| Primary | 10885380151255 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius