FDA UDI
In Commercial Distribution
🇺🇸 United States
NAMIC
DI: 20193489066897
·
Model: 80097003
·
MEDLINE INDUSTRIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
Basic Information
- Brand Name
- NAMIC
- Primary DI
- 20193489066897
- Version / Model
- 80097003
- Catalog Number
- 80097003
- Company Name
- MEDLINE INDUSTRIES, INC.
- Labeler DUNS
- 025460908
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2021-05-12
- Public Version
- 1
- Public Version Date
- 2021-05-20
- Public Version Status
- New
- Public Device Record Key
- add4e1d9-89b4-40d4-9cef-c2f1c74dfce0
Device Description
SYRINGE 12ML PP/FR MLL OEM PG
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DXT | Injector and syringe, angiographic | Cardiovascular | 870.1650 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 15286 | Angiographic syringe | A sterile, manually-operated device consisting of a barrel (cylinder) with plunger intended to be used for the administration of a contrast medium into the heart, great vessels, and coronary arteries to study the heart and vessels under x-ray photography. It may in addition be intended for introduction of other fluids (e.g., saline). It is not intended to be used with a contrast medium injection system. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 10193489066890 | GS1 | ||||
| Primary | 20193489066897 | GS1 |
Customer Contacts
- Phone
- +1(800)633-5463
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K873955 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | FALSE |