FDA.reportPublic FDA data

Hospitak, Mouth to Mask Resuscitator with Filter Infant Mask

Primary DI
00084424900573
Brand
Hospitak, Mouth to Mask Resuscitator with Filter Infant Mask
Company
UNOMEDICAL, INC.
Model
1055-E
Catalog number
1055-E
Device description
Hospitak, Mouth to Mask Resuscitator with Filter Infant Mask
Published
2015-10-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
BTMVentilator, Emergency, Manual (Resuscitator)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTMVentilator, Emergency, Manual (Resuscitator)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K873286000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K873286000DISPOSABLE, MANUAL PULMONARY RESUSCITATORHospitak, Inc.1987-10-26BTM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20844249005747PackageGS120In Commercial Distribution
00084424900573PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2084424900574720844249005747
00084424900573000844249005730844249005730084424900573

GMDN Terms#

Term, Definition table
TermDefinition
Resuscitator face mask, single-useA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
030271837
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00084424900334Hospitak, Mouth to Mask Resuscitator with Filter Adult Large Mask1059-E1059-E2015-10-15
00084424900604Hospitak, Mouth to Mask Resuscitator with Filter Child Mask1056-E1056-E2015-10-15
00084424900574Hospitak, Mouth to Mask Resuscitator with Filter Infant Mask1055-E1055-E2015-10-15
00084424900062Unomedical, Mouth to Mask Resuscitator with Filter1058MM1058MM2015-10-15
00084424900333Hospitak, Mouth to Mask Resuscitator Adult Medium 1058-E1058-E2015-10-15
00084424900423Hospitak, Resuscitator with Filter Adult, No Mask880-E880-E2015-10-15
00084424900605Hospitak, Mouth to Mask Resuscitator with Filter A1057-E1057-E2015-10-15

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