N/A Hytrel hose22F cuff, L= 110 cm

GUDID 04710810085932

GALEMED CORPORATION

Ventilator IMV supplemental circuit, reusable

• Primary Device ID: 04710810085932
• NIH Device Record Key: 463597ca-9692-4e82-aea4-a80fe4f243ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: 38030
• Catalog Number: Hytrel hose22F cuff, L= 110 cm
• Company DUNS: 656854379
• Company Name: GALEMED CORPORATION
• Device Count: 1
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• 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
• 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	04710810085932 [Primary]
GS1	44710810085930 [Package]; Package: Carton [50 Units]; In Commercial Distribution

FDA Product Code

• BZO: Set, Tubing And Support, Ventilator (W Harness)

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: 2015-10-15

On-Brand Devices [N/A]

• 44710810115125: 70065
• 44710810114173: 75186
• 44710810114166: 75185
• 04710810104527: PU-71035
• 44710810089587: 77643
• 04710810088919: 72224
• 44710810088696: 5301
• 44710810088627: 77641
• 44710810088146: 38032
• 44710810086401: 74507
• 04710810085932: 38030
• 44710810085589: 77021
• 44710810085336: 70105
• 44710810084834: 74049
• 44710810084476: 70106
• 44710810084223: 77642
• 44710810083691: 2421
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• 44710810083264: 73041
• 44710810082380: 77022
• 44710810080683: 74048
• 44710810080164: 2425
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• 44710810110106: 6806
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• 44710810111400: 6710
• 44710810111349: 6803
• 44710810111295: 4521
• 44710810110991: 7105
• 44710810110496: 6733
• 44710810089457: 6805
• 44710810088290: 6801
• 44710810084605: 4509
• 44710810083035: 4506
• 44710810081758: 5150