FDA UDI
In Commercial Distribution
🇺🇸 United States
Medical Action Industries
DI: 20809160156565
·
Model: 77338
·
MEDICAL ACTION INDUSTRIES INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
3500
Basic Information
- Brand Name
- Medical Action Industries
- Primary DI
- 20809160156565
- Version / Model
- 77338
- Company Name
- MEDICAL ACTION INDUSTRIES INC.
- Labeler DUNS
- 092364462
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 3500
- Record Status
- Published
- Publish Date
- 2017-07-20
- Public Version
- 4
- Public Version Date
- 2020-10-06
- Public Version Status
- Update
- Public Device Record Key
- 56bf06bd-d89d-4ec6-a2d3-86e04cd8f394
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| LYV | LABEL OR TAG, STERILE | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61345 | Arterial/central venous catheterization support/maintenance kit, non-medicated | A collection of devices intended to support the catheterization procedure of an artery and/or central vein (large veins of the upper body), and/or to provide ongoing vascular catheter maintenance (e.g., dressing change, catheter flushing). Primarily intended to be used at the patient’s bedside, the kit includes devices such as: personal protective equipment (PPE), drapes, disinfectant wipes, dressings, needles, syringes, tourniquets, ultrasound transducer cover, coupling gel, sharps container, and saline solution; neither the catheter, catheter introduction device, nor pharmaceuticals are included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 20809160156565 | GS1 | ||||
| Unit of Use | 10809160156568 | GS1 |