GaleMed

GUDID 44710810082915

Disposable Adjustable PEEP Valve 5-20cmH2O

GaleMed Xiamen Co., Ltd.

PEEP valve, single-use

• Primary Device ID: 44710810082915
• NIH Device Record Key: bdd57339-409b-4d60-b6b6-5702e556d9e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GaleMed
• Version Model Number: 2429-01
• Company DUNS: 527333326
• Company Name: GaleMed Xiamen Co., Ltd.
• Device Count: 20
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	24710810082911 [Primary]
GS1	44710810082915 [Package]; Contains: 24710810082911; Package: Carton [5 Units]; In Commercial Distribution
GS1	94710810082910 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133957

FDA Product Code

• BYE: Attachment, Breathing, Positive End Expiratory Pressure

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: 2015-09-19

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• 44710810082915: Disposable Adjustable PEEP Valve 5-20cmH2O