DoubleCHEK

GUDID 05060692190040

ENTERAL ACCESS TECHNOLOGIES LTD

Exhaled-gas oesophageal intubation detector

• Primary Device ID: 05060692190040
• NIH Device Record Key: 34e3811d-725a-48da-acb3-1fb29f561d5e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DoubleCHEK
• Version Model Number: DC-1001
• Company DUNS: 223906575
• Company Name: ENTERAL ACCESS TECHNOLOGIES LTD
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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: +4401517053466
• Email: xx@xx.xx
• Phone: +4401517053466
• Email: xx@xx.xx
• Phone: +4401517053466
• Email: xx@xx.xx
• Phone: +4401517053466
• Email: xx@xx.xx
• Phone: +4401517053466
• Email: xx@xx.xx
• Phone: +4401517053466
• Email: xx@xx.xx
• Phone: +4401517053466
• Email: xx@xx.xx
• Phone: +4401517053466
• Email: xx@xx.xx
• Phone: +4401517053466
• Email: xx@xx.xx
• Phone: +4401517053466
• Email: xx@xx.xx
• Phone: +4401517053466
• Email: xx@xx.xx
• Phone: +4401517053466
• Email: xx@xx.xx
• Phone: +4401517053466
• Email: xx@xx.xx
• Phone: +4401517053466
• Email: xx@xx.xx
• Phone: +4401517053466
• Email: xx@xx.xx
• Phone: +4401517053466
• Email: xx@xx.xx
• Phone: +4401517053466
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060692190033 [Primary]
GS1	05060692190040 [Package]; Contains: 05060692190033; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212316

FDA Product Code

• KNT: Tubes, Gastrointestinal (And Accessories)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-14
• Device Publish Date: 2024-10-06