FDA.reportPublic FDA data

Unomedical, Mouth to Mask Resuscitator with Filter

Primary DI
00084424900062
Brand
Unomedical, Mouth to Mask Resuscitator with Filter
Company
UNOMEDICAL, INC.
Model
1058MM
Catalog number
1058MM
Device description
Unomedical, Mouth to Mask Resuscitator with Filter Adult 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
10844249000622PackageGS110In Commercial Distribution
20844249000629PackageGS12In Commercial Distribution
00084424900062PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084424900062210844249000622
2084424900062920844249000629
00084424900062000844249000620844249000620084424900062

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
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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Primary DI, Brand, Company table
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