FDA UDI
In Commercial Distribution
🇺🇸 United States
Medical Action Industries
DI: 10809160131336
·
Model: 76395
·
MEDICAL ACTION INDUSTRIES INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Medical Action Industries
- Primary DI
- 10809160131336
- Version / Model
- 76395
- Company Name
- MEDICAL ACTION INDUSTRIES INC.
- Labeler DUNS
- 092364462
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-03-06
- Public Version
- 3
- Public Version Date
- 2021-04-07
- Public Version Status
- Update
- Public Device Record Key
- 93fc8366-5fc3-4885-8117-160117a4fa49
Device Description
NA NA Combo No Disposable/Sngle Use FDA Class II Kit No Latex Latex Free Natural Rubber LTX Non Sterile Prescription Use RX
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- Yes
- Not Made with NRL
- No
- 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 |
|---|---|---|---|---|
| OFM | Phlebotomy blood collection kit | Cardiovascular | 870.2750 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58497 | Blood collection set, invasive | A collection of devices intended to be used by a healthcare professional, in combination with evacuated blood collection tubes, for the routine collection of multiple blood specimens from a patient, via one venipuncture, for clinical analyses. It consists of a blood collection needle or venous butterfly/scalp vein needle and additional devices that may include tubing, male/female Luer-lock connectors, clamps, and a blood collection tube holder. Blood access is directly through the vein with the needle. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20809160131333 | GS1 | 20 | In Commercial Distribution | ||
| Primary | 10809160131336 | GS1 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- STORE AT ROOM TEMPERATURE
- Type
- Special Storage Condition, Specify