GaleMed 4524-HD

GUDID 44710810100305

MANOMETER

GaleMed Xiamen Co., Ltd.

Airway pressure monitor, non-powered

• Primary Device ID: 44710810100305
• NIH Device Record Key: c61442ed-b47b-446d-a180-afbffd5bd7c4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GaleMed
• Version Model Number: 5409
• Catalog Number: 4524-HD
• Company DUNS: 527333326
• Company Name: GaleMed 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04710810100307 [Primary]
GS1	24710810100301 [Package]; Contains: 04710810100307; Package: Box [25 Units]; In Commercial Distribution
GS1	44710810100305 [Package]; Contains: 24710810100301; Package: Carton [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102377

FDA Product Code

• CAP: Monitor, Airway Pressure (Includes Gauge And/Or Alarm)

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

On-Brand Devices [GaleMed]

• 44710810114104: Neonate Straight Connector 10F , 10M/7.6F
• 44710810101791: Rescu-6 Manual Resuscitator, Infant w/ Mask #1
• 44710810101777: Rescu-6 Manual Resuscitator, Child w/ Mask #3
• 44710810101753: Rescu-6 Manual Resuscitator, Adult w/ Mask #5
• 44710810100305: MANOMETER
• 44710810085206: Child Wye Connector 15M w/Pressure Port
• 44710810085169: Disposable Tee Valve
• 44710810084315: Disposable Swivel Wye 22M
• 04710810084126: CV-3 Single Limb Manifold
• 44710810083813: Neonate Wye Connector 10M w/ Pressure Port
• 44710810082946: Disposable Elbow 15M, 22/15mm, 6M
• 44710810082656: Disposable Straight Connector 15M,7.6F Port&Cap,22/15mm
• 44710810082038: Disposable Tube Clip 22mm
• 44710810080690: Disposable Bi-Wye Connector 22M
• 44710810082915: Disposable Adjustable PEEP Valve 5-20cmH2O