Manual Resuscitator 38007

GUDID 00813830022841

ACCUTRON, INC.

Oxygen/air/nitrous oxide breathing gas mixer Oxygen/air/nitrous oxide breathing gas mixer Pulmonary resuscitator, manual, reusable Pulmonary resuscitator, manual, reusable Pulmonary resuscitator, manual, reusable Pulmonary resuscitator, manual, reusable Pulmonary resuscitator, manual, reusable Pulmonary resuscitator, manual, reusable Pulmonary resuscitator, manual, reusable Pulmonary resuscitator, manual, reusable Pulmonary resuscitator, manual, reusable Pulmonary resuscitator, manual, reusable Pulmonary resuscitator, manual, reusable Pulmonary resuscitator, manual, reusable Pulmonary resuscitator, manual, reusable Pulmonary resuscitator, manual, reusable Pulmonary resuscitator, manual, reusable Pulmonary resuscitator, manual, reusable Pulmonary resuscitator, manual, reusable Pulmonary resuscitator, manual, reusable

• Primary Device ID: 00813830022841
• NIH Device Record Key: d4632026-2cc1-4f26-9a4d-4d2123edce62
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Manual Resuscitator
• Version Model Number: 38007
• Catalog Number: 38007
• Company DUNS: 088302096
• Company Name: ACCUTRON, INC.
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813830022841 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K910040

FDA Product Code

• BTM: Ventilator, Emergency, Manual (Resuscitator)

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: 2016-09-26

Devices Manufactured by ACCUTRON, INC.

• 00813830028171 - WAGD Chemetron x 1/2" MNPT: 2023-11-28
• 00813830021066 - FRU, Vacuum Connector With Barbs: 2023-10-13
• 00813830022094 - Accutron Vacuum Male Connector: 2023-10-13
• 00813830026856 - FRU, Axess Vacuum Gauge: 2023-10-13
• 00813830026924 - FRU, Valve, Pressure Relief, Digi-Flo: 2023-10-13
• 00813830026979 - FRU, Gauge Newport O2: 2023-10-13
• 00813830027006 - FRU, O2 Hose, 2 Cyl.: 2023-10-13
• 00813830027013 - FRU, N2O Hose, 2 Cyl.: 2023-10-13