GFA Production

GUDID 06970529420013

GFA Production (Xiamen) Co., Ltd.

Non-rebreathing valve, single-use

• Primary Device ID: 06970529420013
• NIH Device Record Key: b2b7aca5-c5ba-4e09-aa61-bc8045862802
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GFA Production
• Version Model Number: CPRBB-1
• Company DUNS: 421256261
• Company Name: GFA Production (Xiamen) Co., 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06970529420013 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112126

FDA Product Code

• CBP: Valve, Non-Rebreathing

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-11-02