Aero-Med
- Primary DI
- 50885380187900
- Brand
- Aero-Med
- Company
- AERO-MED, LLC
- Model
- CA38275
- Catalog number
- CA38275
- Device description
- Prostate Biopsy Kit for Cottage Health - PDL only
- 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 |
|---|
| 50885380187900 | Package | GS1 | 10 | In Commercial Distribution |
| 10885380187902 | Primary | GS1 | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Blood/tissue storage/culture container | A receptacle intended for the storage and/or culture of tissue, cells, blood or blood components (e.g., peripheral blood stem cells) typically for subsequent therapeutic applications. It has a variety of shapes and sizes, may reduce the risk of contamination, may be used during freezing, and may be gas permeable. This is a single-use device. |
Regulatory Flags
- DUNS number
- 194550042
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- 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
Other Devices From This Company
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 50192253061039 | Aero-Med | AERO-MED, LLC | OIB | 2026-02-20 |
| 50192253061091 | Aero-Med | AERO-MED, LLC | OIB | 2026-02-20 |
| 50192253061107 | Aero-Med | AERO-MED, LLC | OIB | 2026-02-20 |
| 50192253061473 | Aero-Med | AERO-MED, LLC | OIB | 2026-02-20 |
| 50192253061480 | Aero-Med | AERO-MED, LLC | OIB | 2026-02-20 |
| 50192253061503 | Aero-Med | AERO-MED, LLC | OIB | 2026-02-20 |
| 50885380176119 | Aero-Med | AERO-MED, LLC | OIB | 2026-02-20 |
| 50885380185036 | Aero-Med | AERO-MED, LLC | OIB | 2026-02-20 |
| 50885380185067 | Aero-Med | AERO-MED, LLC | OIB | 2026-02-20 |
| 50885380185166 | Aero-Med | AERO-MED, LLC | OIB | 2026-02-20 |
| 50885380185180 | Aero-Med | AERO-MED, LLC | OIB | 2026-02-20 |
| 50885380186521 | Aero-Med | AERO-MED, LLC | OIB | 2026-02-20 |
| 50885380186569 | Aero-Med | AERO-MED, LLC | OIB | 2026-02-20 |
| 50885380186590 | Aero-Med | AERO-MED, LLC | OIB | 2026-02-20 |
| 50885380186644 | Aero-Med | AERO-MED, LLC | OIB | 2026-02-20 |
| 50885380186668 | Aero-Med | AERO-MED, LLC | OIB | 2026-02-20 |
| 50885380186675 | Aero-Med | AERO-MED, LLC | OIB | 2026-02-20 |
| 50885380188525 | Aero-Med | AERO-MED, LLC | OIB | 2026-02-20 |
| 50885380188662 | Aero-Med | AERO-MED, LLC | OIB | 2026-02-20 |
| 50885380188754 | Aero-Med | AERO-MED, LLC | OIB | 2026-02-20 |
| 50885380188761 | Aero-Med | AERO-MED, LLC | OIB | 2026-02-20 |
| 50885380188792 | Aero-Med | AERO-MED, LLC | OIB | 2026-02-20 |
| 50885380189157 | Aero-Med | AERO-MED, LLC | OIB | 2026-02-20 |
| 50885380189393 | Aero-Med | AERO-MED, LLC | OIB | 2026-02-20 |
| 50885380189409 | Aero-Med | AERO-MED, LLC | OIB | 2026-02-20 |
| 50885380189447 | Aero-Med | AERO-MED, LLC | OIB | 2026-02-20 |
| 50885380189454 | Aero-Med | AERO-MED, LLC | OIB | 2026-02-20 |
| 50885380189898 | Aero-Med | AERO-MED, LLC | OIB | 2026-02-20 |
| 50885380190979 | Aero-Med | AERO-MED, LLC | OIB | 2026-02-20 |
| 50885380192850 | Aero-Med | AERO-MED, LLC | OIB | 2026-02-20 |