DEVICE: HIGH FLOW INSUFFLATION UNIT (04953170324147)
Device Identifier (DI) Information
HIGH FLOW INSUFFLATION UNIT
UHI-4
In Commercial Distribution
OLYMPUS MEDICAL SYSTEMS CORP.
UHI-4
In Commercial Distribution
OLYMPUS MEDICAL SYSTEMS CORP.
"UHI-4 45L HIGHFLOW INSUFFLATION UNIT"
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? |
---|---|---|---|---|
16849 | Laparoscopic insufflator |
A mains electricity (AC-powered) device designed to distend the peritoneal cavity by filling it with a pressure-limited gas [typically carbon dioxide (CO2)] providing the operator with a space (pneumoperitoneum) in which to perform an examination or surgical intervention. Electronics assist in monitoring the pressure and maintaining the gas-filled space by compensating for gas leakage. Other surgical instruments may be introduced into the peritoneal cavity through other laparoscopic ports. This device may also be referred to as a gas distention system.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FCX | INSUFFLATOR, AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE |
HIF | INSUFFLATOR, LAPAROSCOPIC |
OSV | Insufflator, endoscopic vessel harvesting |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K122180 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
f9bae455-e91f-482d-801e-184d5bfe19c1
April 22, 2024
5
September 21, 2016
April 22, 2024
5
September 21, 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 |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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)401-1086
xx@xx.xx
xx@xx.xx