Aero-Med
- Primary DI
- 50810010892176
- Brand
- Aero-Med
- Company
- Aero-Med, Ltd.
- Model
- LCA188
- Catalog number
- LCA188
- Device description
- Single Test Pack, HA Quantiferon TB
- Published
- 2019-09-13
- 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 |
|---|
| 50810010892176 | Package | GS1 | 24 | In Commercial Distribution |
| 00810010892171 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 50810010892176 | 50810010892176 | | |
| 00810010892171 | 00810010892171 | 810010892171 | 0810010892171 |
GMDN Terms
| Term | Definition |
|---|
| Phlebotomy kit | A collection of devices and supplies used in the practice of collecting blood samples. It typically consists of test tubes, racks, needles, bandages, gauze pads, and a sharps container. This is a single-use device. |
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
- false
- Sterilization required before use
- false
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|---|
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| 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 |
| 50885380187900 | 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 |