DEVICE: NA (00816765013151)

Device Identifier (DI) Information

NA
710602
Not in Commercial Distribution
710602
US Endoscopy
00816765013151
GS1
March 31, 2020
1
627879687 *Terms of Use
The Two tank shuttle valve system is for use with an insufflator to attach two medical grade CO2 cylinders simultaneously. This reduces the likelihood of running out of CO2 during a procedure.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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?
14239 High-pressure medical gas hose
A length of flexible tube intended to deliver and withstand gases under very high pressure, e.g., greater than 200 bar/3000 pounds per square inch (psi). It may be composed of any of several malleable or semi-rigid materials (e.g., plastic, rubber, or nylon), and braided with cotton wool and/or stainless steel. It is typically used to transport high pressure compressed medical gas to a pressure regulating device. It is available in various lengths, including standard coil lengths. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FCX INSUFFLATOR, AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K053008 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

dd729a82-44cc-4b73-985e-7d7c5af0f597
July 04, 2022
6
September 17, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
+1(800)548-4873
xx@xx.xx
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