FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Aero-Med
DI: 10885380177019
·
Model: CA26775
·
AERO-MED, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Aero-Med
- Primary DI
- 10885380177019
- Version / Model
- CA26775
- Catalog Number
- CA26775
- Company Name
- AERO-MED, LLC
- Labeler DUNS
- 194550042
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-02-04
- Public Version
- 4
- Public Version Date
- 2025-07-04
- Public Version Status
- Update
- Public Device Record Key
- cf608a75-6eab-4105-8454-d8602572ed56
- Distribution End Date
- 2025-07-03
Device Description
24 Hour UA Mail Back Kit, Mayo Clinic Scottsdale
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
- 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
- No
- 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 |
|---|---|---|---|---|
| 61352 | Faecal specimen collection kit IVD, home-use | A collection of devices and materials intended to be used by a layperson in the home to self-collect a faecal (stool) sample for subsequent in vitro diagnostic testing or screening purposes (e.g., occult blood, cytology) in a clinical laboratory. The kit may consist of a specimen container(s) with or without an additive/medium (e.g., cell or nucleic acid preservative solution, Carey-Blair transport medium), collection assistive device(s) (e.g., blush, spatula), gloves, labels, and/or a return packing/envelope for submission/mailing to the clinical laboratory. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50885380177017 | GS1 | CASE | 4 | Not in Commercial Distribution | 2025-07-03 |
| Primary | 10885380177019 | GS1 |