SMITH & NEPHEW 400 7209933

GUDID 00885554012286

S&N 400 INSUFFLATOR KIT US

Smith & Nephew, Inc.

Insufflation gas conditioning system control unit

• Primary Device ID: 00885554012286
• NIH Device Record Key: e272261f-03e3-4d65-9394-ed2f0e011dc3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SMITH & NEPHEW 400
• Version Model Number: 7209933
• Catalog Number: 7209933
• Company DUNS: 109903521
• Company Name: Smith & Nephew, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885554012286 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022052

FDA Product Code

• HIF: INSUFFLATOR, LAPAROSCOPIC

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-31
• Device Publish Date: 2015-08-30

On-Brand Devices [SMITH & NEPHEW 400]

• 00885554012286: S&N 400 INSUFFLATOR KIT US
• 00885554011821: S&N 400 INSUFFLATOR KIT ITALIAN
• 00885554011418: S&N 400 INSUFFLATOR KIT FRENCH
• 00885554011203: S&N 400 INSUFFLATOR KIT SPANISH
• 00885554010671: S&N 400 INSUFFLATOR KIT UK
• 03596010542359: S&N 400 INSUFFLATOR KIT GERMAN