FDA UDI
In Commercial Distribution
🇺🇸 United States
Aero-Med
DI: 10810010890983
·
Model: CMT02
·
Aero-Med, Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
25
Basic Information
- Brand Name
- Aero-Med
- Primary DI
- 10810010890983
- Version / Model
- CMT02
- Catalog Number
- CMT02
- Company Name
- Aero-Med, Ltd.
- Labeler DUNS
- 194550042
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2019-03-27
- Public Version
- 1
- Public Version Date
- 2019-04-04
- Public Version Status
- New
- Public Device Record Key
- 7fb9d37c-0071-4e03-a137-7ae78e568f86
Device Description
Serum Separator Card
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
- Yes
- 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 |
|---|---|---|---|---|
| LRP | TRAY, SURGICAL | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 18026 | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10810010890983 | GS1 | ||||
| Unit of Use | 70810010890985 | GS1 |