N/A

GUDID 46923980114340

PEEP Valve, 5-20cmH2O, 30F w/adapter

GaleMed Xiamen Co., Ltd.

PEEP valve, single-use

• Primary Device ID: 46923980114340
• NIH Device Record Key: cad1695e-9f31-4ab2-906b-37e6b1dba2a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: XML0004
• Company DUNS: 527333326
• Company Name: GaleMed Xiamen Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06923980114342 [Primary]
GS1	46923980114340 [Package]; Contains: 06923980114342; Package: Carton [10 Units]; In Commercial Distribution

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-09-19
• Device Publish Date: 2024-09-11

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• 46923980114340: PEEP Valve, 5-20cmH2O, 30F w/adapter