FDA.reportPublic FDA data

Hospitak, Mouth to Mask Resuscitator with Filter A

Primary DI
00084424900605
Brand
Hospitak, Mouth to Mask Resuscitator with Filter A
Company
UNOMEDICAL, INC.
Model
1057-E
Catalog number
1057-E
Device description
Hospitak, Mouth to Mask Resuscitator with Filter Adult Small Mask
Published
2015-10-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does n
Rx
true
OTC
false
Sterile
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20844249006058PackageGS120In Commercial Distribution
00084424900605PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2084424900605820844249006058
00084424900605000844249006050844249006050084424900605

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00084424900573Hospitak, Mouth to Mask Resuscitator with Filter Infant Mask1055-E1055-E2015-10-15
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

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Primary DI, Brand, Company table
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