DEVICE: Coeur Nemoto (M902551550)
Device Identifier (DI) Information
Coeur Nemoto
C855-5155
In Commercial Distribution
C855-5155
COEUR, INC.
C855-5155
In Commercial Distribution
C855-5155
COEUR, INC.
100mL/50mL CT Dual Syringe Pack Includes (1) Y-set /(1) Check Valve / (2) Fill Spikes
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
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.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DXT | Injector And Syringe, Angiographic |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K051799 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Keep product in clean, dry location. Avoid direct rays, heat and high humidity, and ultraviolet rays such as a germicidal light. |
Clinically Relevant Size
[?]Size Type Text |
---|
Total Volume: 50 Milliliter |
Total Volume: 100 Milliliter |
Device Record Status
b35df932-8c2e-4dfd-8aba-245865e3e90e
July 06, 2018
3
July 14, 2016
July 06, 2018
3
July 14, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
M902551556 | 20 | M902551550 | In Commercial Distribution | shipper |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-800-296-5893
customer.service@coeurinc.com
customer.service@coeurinc.com