7209944

GUDID 03596010500601

GAS WARMER IN-LINE S&N

Smith & Nephew, Inc.

Insufflation gas conditioning system control unit
Primary Device ID03596010500601
NIH Device Record Keybaf9e8c9-b16e-4c4e-a7bb-350161dcc3e5
Commercial Distribution StatusIn Commercial Distribution
Version Model Number7209944
Catalog Number7209944
Company DUNS109903521
Company NameSmith & Nephew, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS103596010500601 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HIFINSUFFLATOR, LAPAROSCOPIC

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-09-17
Device Publish Date2015-08-30

Devices Manufactured by Smith & Nephew, Inc.

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00885556891612 - CATALYSTEM2024-08-15 CATALYSTEM COLLARED STEM STANDARD OFFSET SIZE 5
00885556891629 - CATALYSTEM2024-08-15 CATALYSTEM COLLARED STEM STANDARD OFFSET SIZE 6
00885556891735 - CATALYSTEM2024-08-15 CATALYSTEM COLLARED STEM HIGH OFFSET SIZE 4
00885556891742 - CATALYSTEM2024-08-15 CATALYSTEM COLLARED HIGH OFFSET SIZE 5
00885556891759 - CATALYSTEM2024-08-15 CATALYSTEM COLLARED STEM HIGH OFFSET SIZE 6
00885556892107 - CATALYSTEM2024-08-07 CATALYSTEM BROACH SIZE 0
00885556892114 - CATALYSTEM2024-08-07 CATALYSTEM BROACH SIZE 1

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