N/A Air-Soft Mask Size 0, Infant

GUDID 44710810088696

GALEMED CORPORATION

Anaesthesia mask strap, reusable

• Primary Device ID: 44710810088696
• NIH Device Record Key: ca6bbde0-5255-40a5-a6a3-09c198306792
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: 5301
• Catalog Number: Air-Soft Mask Size 0, Infant
• Company DUNS: 656854379
• Company Name: GALEMED CORPORATION
• 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: 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	04710810088698 [Primary]
GS1	44710810088696 [Package]; Contains: 04710810088698; Package: Carton [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K951043

FDA Product Code

• BSJ: Mask, Gas, Anesthetic

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: 2015-10-15

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
• 44710810083684: 2422
• 44710810083516: 76246
• 44710810083264: 73041
• 44710810082380: 77022
• 44710810080683: 74048
• 44710810080164: 2425
• 44710810080157: 2423
• 44710810110168: 71054
• 44710810110106: 6806
• 44710810110090: 6802
• 44710810085923: 2464
• 44710810085916: 2463
• 44710810085909: 2462
• 44710810085893: 2461
• 44710810085688: 4503
• 44710810085152: 2483
• 44710810085145: 2482
• 44710810085138: 2481
• 44710810085121: 2474
• 44710810085114: 2473
• 44710810085107: 2472
• 44710810085091: 2471
• 44710810084902: 2484
• 44710810111400: 6710
• 44710810111349: 6803
• 44710810111295: 4521
• 44710810110991: 7105
• 44710810110496: 6733
• 44710810089457: 6805
• 44710810088290: 6801
• 44710810084605: 4509
• 44710810083035: 4506
• 44710810081758: 5150