DEVICE: N/A (00885556568125)
Device Identifier (DI) Information
N/A
7205832F
Not in Commercial Distribution
7205832F
Smith & Nephew, Inc.
7205832F
Not in Commercial Distribution
7205832F
Smith & Nephew, Inc.
RFB INSUFFLATORDYONICS(R)
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
48169 | Insufflation gas conditioning system control unit |
A mains electricity (AC-powered) device designed to be used together with a laparoscopic gas distention system or other gas source to condition the insufflation gas stream [typically carbon dioxide (CO2)] by automatically heating and humidifying the gas before introduction into the peritoneal cavity or a wound during laparoscopic or open surgery. It is electronically controlled and has controls and displays for the user to operate and monitor the gas conditioning process which happens within an interchangeable humidification chamber that is fitted to this device. The gas is delivered to the operative site via a dedicated heated tubing set.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HIF | INSUFFLATOR, LAPAROSCOPIC |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K983326 | 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
2d09da7b-982f-4a73-80bd-f3f4e31d80e0
September 07, 2023
6
September 28, 2015
September 07, 2023
6
September 28, 2015
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 |
---|---|
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)238-7538
GUDID@SMITH-NEPHEW.COM
GUDID@SMITH-NEPHEW.COM