NAMIC
- Primary DI
- 20193489059028
- Company
- MEDLINE INDUSTRIES, INC.
- Model
- 64046007
- Catalog number
- 64046007
- Device description
- MTO BAG CONTRAST BOTTLE HANGER 50CC PG
- Published
- 2021-07-26
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Regulatory Flags
- DUNS number
- 025460908
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- 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
- true
- Sterilization required before use
- false
Identifiers
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 20193489059028 | Package | GS1 | 20 | In Commercial Distribution |
| 10193489059458 | Primary | GS1 | 0 | |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Package type | Contains DI | Discontinue date | Status |
|---|
| 20193489059028 | Package | GS1 | 20 | BOX | 10193489059458 | | In Commercial Distribution |
| 10193489059458 | Primary | GS1 | 0 | | | | |
Product Codes
| Code | Name | Class | Specialty | Regulation | Implant | Malfunction reporting |
|---|
| IZI | System, X-Ray, Angiographic | 2 | Radiology | 892.1600 | N | Eligible |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|
| K903493 | 000 | NAMIC CONTRAST SAVINGS DELIVERY SYSTEM | North American Instrument Corp. | 1991-03-26 | IZI |
GMDN Terms
| Term | Definition |
|---|
| Contrast medium conservation system | An assembly of electromechanical devices that serves a contrast medium injector system by controlling the amount of contrast agent supplied to the syringe/injector portion of the contrast medium injector system. It is designed to optimise the use of injectible contrast agents in order to prevent unnecessary waste of contrast media during and/or between patient procedures. |
Device Sizes
No records found.
Storage And Handling
No records found.
Contacts
| Phone | Email |
|---|
| +1(800)633-5463 | service@medline.com |
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