FDA.reportPublic FDA data

Medi-First CPR Kit

Primary DI
50347682802108
Brand
Medi-First CPR Kit
Company
Medique Products
Model
8021B
Catalog number
8021B
Device description
1 CPR Mask 1 Pair Nitrile Gloves 2 Benzalkonium Chloride 0.133% Wipes
Published
2020-08-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
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
50347682802108PackageGS130In Commercial Distribution
00347682802103PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5034768280210850347682802108
00347682802103003476828021033476828021030347682802103

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-634-7680cs@mediqueproducts.com

Regulatory Flags#

DUNS number
086911794
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
true
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
true
Sterilization required before use
false

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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00634376498576(HEALTH & SAFETY INSTITUTE) HSI CPR REDI-SHIELD with keyring case & gloves RONDEX PRODUCTS, INCORPORATEDCBP2023-01-02
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