DEVICE: ICU Medical (00887709010390)
Device Identifier (DI) Information
ICU Medical
B5900-10
In Commercial Distribution
B5900-10
ICU MEDICAL, INC.
B5900-10
In Commercial Distribution
B5900-10
ICU MEDICAL, INC.
121" (307 cm) Appx 15.7 mL, 60 Drop 24 Hour Primary Set w/2 MicroClave™, 1o2™ Valve, Rotating Luer, 1 Ext
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? |
---|---|---|---|---|
58977 | Basic intravenous administration set, noninvasive |
A collection of noninvasive devices intended to conduct fluids from an intravenous (IV) administration bag/bottle to a peripheral venous cannula (not included) during gravitational or pump administration to a patient's venous system; some types may in addition be intended for enteral feeding applications. It typically includes tubing, connectors, chambers, and clamps; the bag/bottle may be included. It neither includes devices intended for invasive use nor a heat exchanger. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FMG | Stopcock, i.V. Set |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K964435 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
91521e22-58a6-4e83-b144-e7011de17ef1
September 01, 2021
1
August 24, 2021
September 01, 2021
1
August 24, 2021
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
10887709010397 | 50 | 00887709010390 | In Commercial Distribution | CS |
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(866)829-9025
customerservice@icumed.com
customerservice@icumed.com