Hospitak, Mouth to Mask Resuscitator with Filter Infant Mask 1055-E

GUDID 00084424900573

Hospitak, Mouth to Mask Resuscitator with Filter Infant Mask

UNOMEDICAL, INC.

Resuscitator face mask, single-use

• Primary Device ID: 00084424900573
• NIH Device Record Key: e83f55a7-024a-439f-bb2d-8a8771449a17
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hospitak, Mouth to Mask Resuscitator with Filter Infant Mask
• Version Model Number: 1055-E
• Catalog Number: 1055-E
• Company DUNS: 030271837
• Company Name: UNOMEDICAL, 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: 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00084424900573 [Primary]
GS1	20844249005747 [Package]; Package: case [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K873286

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: 4
• Public Version Date: 2019-08-14
• Device Publish Date: 2015-10-15

On-Brand Devices [Hospitak, Mouth to Mask Resuscitator with Filter Infant Mask]

• 00084424900574: Hospitak, Mouth to Mask Resuscitator with Filter Infant Mask
• 00084424900573: Hospitak, Mouth to Mask Resuscitator with Filter Infant Mask