DEVICE: Medical Imaging Solutions International (06938327900038)
Device Identifier (DI) Information
Medical Imaging Solutions International
200101-A
In Commercial Distribution
100301
Shenzhen Baoan Medical Supply Co., Ltd.
200101-A
In Commercial Distribution
100301
Shenzhen Baoan Medical Supply Co., Ltd.
2-65 mL Syringes
1-Large Spike, 1-Small Spike
1-96" Y Coiled Tubing with Dual Check Valves
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
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. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DXT | Injector And Syringe, Angiographic |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K151960 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
37c2c929-2177-4904-a725-4efe3c2c6126
July 06, 2018
5
November 11, 2016
July 06, 2018
5
November 11, 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 |
---|---|---|---|---|---|
26938327900038 | 50 | 06938327900038 | In Commercial Distribution | Carton |
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
[?]
1-800-603-6501
orders@misisyringes.com
orders@misisyringes.com