Aero-Med
- Primary DI
- 50192253061091
- Brand
- Aero-Med
- Company
- AERO-MED, LLC
- Model
- CA39450
- Catalog number
- CA39450
- Device description
- CA39450 ProPath Urine Kit
- Published
- 2026-02-20
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- true
- Sterile
- false
- Single use
- true
Product Codes
| Code | Name |
|---|
| OIB | Blood and urine collection kit (excludes HIV testing) |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| OIB | Blood And Urine Collection Kit (Excludes Hiv Testing) | Pathology | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 50192253061091 | Package | GS1 | 100 | In Commercial Distribution |
| 10192253061093 | Primary | GS1 | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Urine specimen collection kit IVD | A collection of noninvasive devices intended to be used for the collection, preservation, and transport of a urine specimen for culture, analysis, and/or other investigation. It typically consists of a primary urine collection receptacle (e.g., cup, conical tube, vessel), a urine preservation/transport tube [typically evacuated, with or without additives], and a transfer device for facilitating the aseptic transfer of a urine sample between receptacles; supportive devices for urine collection (e.g., wet wipes, absorbent pads, Foley catheter connector) and/or analysis [e.g., microscope slides, tube rack] may also be included in the kit. This is a single-use device. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Storage Environment Temperature | 4 Degrees Celsius | 25 Degrees Celsius | |
Regulatory Flags
- DUNS number
- 194550042
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- false
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|---|
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