HIGH FLOW INSUFFLATION UNIT

GUDID 04953170324147

"UHI-4 45L HIGHFLOW INSUFFLATION UNIT"

OLYMPUS MEDICAL SYSTEMS CORP.

Laparoscopic insufflator Laparoscopic insufflator Laparoscopic insufflator Laparoscopic insufflator Laparoscopic insufflator Laparoscopic insufflator Laparoscopic insufflator Laparoscopic insufflator Laparoscopic insufflator Laparoscopic insufflator Laparoscopic insufflator Laparoscopic insufflator Laparoscopic insufflator Laparoscopic insufflator Laparoscopic insufflator Laparoscopic insufflator Laparoscopic insufflator Laparoscopic insufflator Laparoscopic insufflator

• Primary Device ID: 04953170324147
• NIH Device Record Key: f9bae455-e91f-482d-801e-184d5bfe19c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HIGH FLOW INSUFFLATION UNIT
• Version Model Number: UHI-4
• Company DUNS: 711789789
• Company Name: OLYMPUS MEDICAL SYSTEMS CORP.
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170324147 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122180

FDA Product Code

• FCX: INSUFFLATOR, AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-21

On-Brand Devices [HIGH FLOW INSUFFLATION UNIT]

• 04953170324147: "UHI-4 45L HIGHFLOW INSUFFLATION UNIT"
• 04953170140297: UHI-3
• 04953170140280: "UHI-3 HIGH FLOW INSUFFLATOR 35 L"