FDA UDI
In Commercial Distribution
🇺🇸 United States
Precision
DI: 20884521151861
·
Model: 7000SA
·
Cardinal Health, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Precision
- Primary DI
- 20884521151861
- Version / Model
- 7000SA
- Catalog Number
- 7000SA
- Company Name
- Cardinal Health, Inc.
- Labeler DUNS
- 080935429
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-06-30
- Public Version
- 4
- Public Version Date
- 2023-09-01
- Public Version Status
- Update
- Public Device Record Key
- a3d3a85e-0aef-48fd-915e-e2240bc2dad1
- Distribution End Date
- 2025-12-31
Device Description
Urine Specimen System with Preservative
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
- 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 |
|---|---|---|---|---|
| FMH | Container, Specimen, Sterile | Pathology | 864.3250 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12542 | Midstream urine specimen container IVD | A covered plastic receptacle with no additives intended to be used for the collection, and preservation and/or transport, of a midstream urine specimen for analysis and/or other investigation. The midstream is collected after an initial pre-measured volume of first-voided urine is diverted to a separate reservoir for discarding. Additional items may be included (e.g., towelettes). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 40884527005957 | GS1 | CASE | 200 | In Commercial Distribution | 2025-12-31 |
| Primary | 20884521151861 | GS1 | ||||
| Package | 10884521151864 | GS1 | PACK_OR_INNER_PACK | 50 | In Commercial Distribution | 2025-12-31 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- ;