FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Aero-Med
DI: 10885380133664
·
Model: CA5625
·
Aero-Med, Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Aero-Med
- Primary DI
- 10885380133664
- Version / Model
- CA5625
- Catalog Number
- CA5625
- Company Name
- Aero-Med, Ltd.
- Labeler DUNS
- 194550042
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-04-12
- Public Version
- 4
- Public Version Date
- 2023-02-01
- Public Version Status
- Update
- Public Device Record Key
- a1ba8a36-7800-4fbe-a7e1-3a46a2d96d46
- Distribution End Date
- 2023-02-01
Device Description
SPECIMEN,URINE COLLECTION,KIT,UC HE
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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 |
|---|---|---|---|---|
| 58177 | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50885380133662 | GS1 | CASE | 50 | Not in Commercial Distribution | 2023-02-01 |
| Primary | 10885380133664 | GS1 |