DEVICE: DUO-VENT (00085412002750)
Device Identifier (DI) Information
DUO-VENT
2C7552
In Commercial Distribution
2C7552
BAXTER INTERNATIONAL INC.
2C7552
In Commercial Distribution
2C7552
BAXTER INTERNATIONAL INC.
Nitroglycerin Set with DUO-VENT Spike, PVC Tubing Segment, Injection Site, Male Luer Lock Adapter
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
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? |
---|---|---|---|---|
16631 | Non-absorbing intravenous administration set |
A collection of sterile devices designed for the intravenous (IV) administration of solutions and manufactured with low-absorption plastics to avoid partial absorption of the components of the infused solutions. It typically consists of plastic tubes made of or lined with non absorbing plastics [e.g., polyethylene (PE), Teflon], to avoid solution contact with polyvinyl chloride (PVC) components; it also includes a check valve, a roller clamp, a Y-site connector, and Luer adaptors. The set is mainly used in high-flow infusion pumps for administration of solutions containing products (e.g., nitroglycerin) that are absorbed by PVC materials. This is a single-use device.
|
Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FPA | Set, administration, intravascular |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K150860 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
0f7ac167-4f76-4b4f-a523-0d338008cf8b
July 06, 2018
3
September 24, 2016
July 06, 2018
3
September 24, 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 |
---|---|---|---|---|---|
50085412002755 | 48 | 00085412002750 | In Commercial Distribution | CASE |
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)933-0303
Medinfo_medproducts@baxter.com
Medinfo_medproducts@baxter.com