Hospitak, Mouth to Mask Resuscitator with Filter Infant Mask

Basic Information

• Brand Name: Hospitak, Mouth to Mask Resuscitator with Filter Infant Mask
• Primary DI: 00084424900573
• Version / Model: 1055-E
• Catalog Number: 1055-E
• Company Name: UNOMEDICAL, INC.
• Labeler DUNS: 030271837
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-15
• Public Version: 5
• Public Version Date: 2022-05-23
• Public Version Status: Update
• Public Device Record Key: e83f55a7-024a-439f-bb2d-8a8771449a17
• Distribution End Date: 2022-05-20

Device Description

Hospitak, Mouth to Mask Resuscitator with Filter Infant Mask

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	868.5915	2

GMDN Terms

Code	Name	Definition	Implantable	Status
57824	Resuscitator face mask, single-use	A non-sterile, flexible, form-shaped device that is placed over a patient's nose and mouth to direct ambient air, or medical oxygen (O2) and air, from a resuscitator to the upper airway and lungs. It is typically made of non-conductive sterilizable materials (e.g., silicone) that will create a gastight seal against the face. It will typically include a 15 mm and/or 22 mm connector and is available in a range of sizes (baby to adult). It will be directly attached to the resuscitator and held in place on the patient's face by the operator. This device is intended for use with a breathing resuscitator but may be used for the delivery of anaesthesia gases. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00084424900573	GS1
Package	20844249005747	GS1	case	20	Not in Commercial Distribution	2022-05-20

Premarket Submissions

Submission Number	Supplement Number
K873286	000