AquaShield 00711550

GUDID 10816765012984

The AquaShield system – Pentax is intended to be used with an air or carbon dioxide (CO2) source from an endoscope with the purpose of supplying sterile water to the endoscope during endoscopic procedures.

US Endoscopy

Endoscopic insufflation tubing set, single-use

• Primary Device ID: 10816765012984
• NIH Device Record Key: 5e7464d1-e471-4068-b0c5-62e99a4dcc0c
• Commercial Distribution Discontinuation: 2020-03-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: AquaShield
• Version Model Number: 711550
• Catalog Number: 00711550
• Company DUNS: 627879687
• Company Name: US Endoscopy
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816765012987 [Primary]
GS1	10816765012984 [Package]; Contains: 00816765012987; Package: Box [25 Units]; Discontinued: 2020-03-31; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153362

FDA Product Code

• FEQ: PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 7
• Public Version Date: 2020-03-31
• Device Publish Date: 2017-01-03

On-Brand Devices [AquaShield]

• 10816765013332: The AquaShield system CO2 – Fujifilm is to be used with an air or carbon dioxide (CO2) source
• 10816765013318: The AquaShield system CO2 – Pentax is intended to be used with an air or carbon dioxide (CO2)
• 10816765012984: The AquaShield system – Pentax is intended to be used with an air or carbon dioxide (CO2) sour
• 10816765012465: The AquaShield system is intended to be used with an air or carbon dioxide (CO2) source with the
• 10816765012458: The AquaShield system is intended to be used with an air source from an endoscope with the purpo
• 10816765012304: The AquaShield CO2 system is intended to be used with an air or carbon dioxide (CO2) source with
• 10816765012229: The AquaShield CO2 system is intended to be used with an air or carbon dioxide (CO2) source with
• 10816765011604: The AquaShield system is intended to be used with an air source from an endoscope with the purpo
• 10724995183889: The AquaShield system CO2 – Fujifilm is to be used with an air or carbon dioxide (CO2) source
• 10724995183872: The AquaShield system CO2 – Pentax is intended to be used with an air or carbon dioxide (CO2)
• 10724995183865: The AquaShield system – Pentax is intended to be used with an air or carbon dioxide (CO2) sour
• 10724995183858: The AquaShield CO2 system is intended to be used with an air or carbon dioxide (CO2) source with
• 10724995183841: The AquaShield system is intended to be used with an air or carbon dioxide (CO2) source with the
• 10724995183834: The AquaShield system is intended to be used with an air source from an endoscope with the purpo
• 10724995183827: The AquaShield CO2 system is intended to be used with an air or carbon dioxide (CO2) source with
• 10724995183810: The AquaShield system is intended to be used with an air source from an endoscope with the purpo