FDA UDI
In Commercial Distribution
🇺🇸 United States
Aero-Med
DI: 10885380203657
·
Model: CA21150A
·
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
- 10885380203657
- Version / Model
- CA21150A
- Catalog Number
- CA21150A
- Company Name
- AERO-MED, LLC
- Labeler DUNS
- 194550042
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-01
- Public Version
- 3
- Public Version Date
- 2025-10-22
- Public Version Status
- Update
- Public Device Record Key
- 82aba1a8-24d2-4b2e-b3ec-a394a48cfa57
Device Description
Kit Urine Foley Collection for Northside Hospital Only
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
- 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 |
|---|---|---|---|---|
| 50276 | Rubella virus total antibody IVD, kit, rapid agglutination, clinical | A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of total antibodies to Rubella virus in a clinical specimen within a short period, relative to standard laboratory testing procedures, using a rapid agglutination method. This is a rapid test commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50885380203655 | GS1 | CASE | 50 | In Commercial Distribution | |
| Primary | 10885380203657 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius