GaleMed

GUDID 44710810114104

Neonate Straight Connector 10F , 10M/7.6F

GaleMed Xiamen Co., Ltd.

Tube/mask breathing circuit connector, single-use, sterile

• Primary Device ID: 44710810114104
• NIH Device Record Key: 07289c1a-16da-4880-a83f-ec9d56c62609
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GaleMed
• Version Model Number: 74007
• Company DUNS: 527333326
• Company Name: GaleMed Xiamen Co., Ltd.
• Device Count: 100
• DM Exempt: false
• Pre-market Exempt: true
• 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
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• 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	04710810114106 [Primary]
GS1	44710810114104 [Package]; Contains: 04710810114106; Package: Carton [10 Units]; In Commercial Distribution
GS1	94710810114109 [Unit of Use]

FDA Product Code

• BZA: Connector, Airway (Extension)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-01-23
• 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