FDA.reportPublic FDA data

Medifirst CPR Mask

Primary DI
00347682802011
Brand
Medifirst CPR Mask
Company
Medique Products
Model
80201
Catalog number
80201
Published
2017-03-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CBPValve, Non-Rebreathing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBPValve, Non-RebreathingAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112126000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112126000GENUINE FIRST AID CPR MASKGenuine First Aid, LLC2011-12-01CBP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30347682802012PackageGS1100In Commercial Distribution
50347682802016PackageGS15In Commercial Distribution
00347682802011PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3034768280201230347682802012
5034768280201650347682802016
00347682802011003476828020113476828020110347682802011

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary resuscitation mask, single-useA flexible, form-shaped device that is placed over a patient's mouth to administer "mouth-to-mask" exhaled air from the user to the patient during cardiopulmonary resuscitation (CPR). The device is designed to replace "mouth-to-mouth" resuscitation therefore reducing the risk of cross-contamination; it is also used on manikins by students during CPR training. The device typically consists of the mask with a mouthpiece and a non-rebreathing valve and/or bacteria filter. Also referred to as a pocket face mask, it is typically used by emergency medical services (EMS) or as part of first aid kits. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-869-6970cs@greenguard.com

Regulatory Flags#

DUNS number
086911794
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00347682713010Medi-First Large Instant Hot Pack71301713012019-07-12
00347682607012"Medi-First Waterproof Latex Free First Aid Tape 1/2"", 5 yds"60701607012019-07-03
00347682641016Medi-Stopper6401641012019-07-12
00347682696016"Medi-First Gauze Compress 24"" x 72"""69601696012019-07-19
00347682898014Medi-First Combine ABD Pad89801898012019-07-12
00347682642129Medi-First Non-Adherent Sterile Pads (10 count)64212642122019-07-12
00347682810016Medi-First Emergency Survival Blanket81001810012019-07-12
00347682623012"Medi-First Elastic Tape 1"" x 5 yards"62301623012019-07-24
00347682656997Medi-First 1/2 x 2 5 yards65699656992019-07-19
00347682660024Medi-First Tourniquet66002660022019-07-12
00347682656225Medi-First Adhesive Tape 1/2 x 2 5 yards656B656B2019-07-19
00347682135126Medi-First Plus Sterile Gauze Pads 2 x 2 (10 count)1035121035122019-07-12
00347682135737Medi-First Plus Sterile Gauze Pads 3 x 3 (25 count)1035731035732019-07-12
00347682136123Medi-First Plus Sterile Gauze Pads 3 x 3 (10 count)1036121036122019-07-12
00347682136734Medi-First Plus Sterile Gauze Pads 4 x 4 (25 count)1036731036732019-07-12
00347682137120Medi-First Plus Sterile Gauze Pads 4 x 4 (10 count)1037121037122019-07-12
00347682137731Medi-First Plus Sterile Gauze Pads 2 x 2 (25 count)1037731037732019-07-12
00347682606121Medi-First Sterile Gauze Pads 2 x 2 (10 count)60612606122019-07-12
00347682606336Medi-First Sterile Gauze Pads 3 x 3 (100 count)60633606332019-07-12
00347682606732Medi-First Sterile Gauze Pads 3 x 3 (25 count)60673606732019-07-12

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Primary DI, Brand, Company table
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