FDA.reportPublic FDA data

CPR POCKET RESUSCITATOR W/TUBE(BLOW MOLDING)

Primary DI
04716770662404
Brand
CPR POCKET RESUSCITATOR W/TUBE(BLOW MOLDING)
Company
BESMED HEALTH BUSINESS CORP.
Model
CP-66240
Device description
CPR POCKET RESUSCITATOR W/TUBE(BLOW MOLDING)
Published
2017-12-08
Public version status
Update
Distribution status
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
K021446000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K021446000OEMEDIC INTERNATIONAL INC. BESMED SILICONE ADULT, CHILD, INFANT MANUAL RESUSCITATOR WITH MASK AND RESERVOIROemedic International, Inc.2002-10-11BTM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04716770662404PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04716770662404047167706624044716770662404

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

Regulatory Flags#

DUNS number
658023775
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04716770703022HMEF W/Luer lock port (Dead space 45ml)FL-703022026-02-11
04716770703039HMEF W/Luer lock port (Dead space 60ml)FL-703032026-02-11
04716770703060HMEF (Dead space 60ml)FL-703062026-02-11
04716770701127HME W/Luer lock port (Dead space 45ml)FL-701122026-02-11
04716770701158Angled HME with luer lock portFL-701152026-02-11
04716770702230Bacterial Filter (Dead space 32ml)FL-702232026-02-11
14716770703029HMEF W/Luer lock port (Dead space 45ml)FL-703022026-02-11
14716770703036HMEF W/Luer lock port (Dead space 60ml)FL-703032026-02-11
14716770703067HMEF (Dead space 60ml)FL-703062026-02-11
04716770341460Besmed Menstrual CupPE-341462022-12-08
04716770341477Besmed Menstrual CupPE-341472022-12-08
04716770341484Besmed Menstrual CupPE-341482022-12-09
04716770341491Besmed Menstrual CupPE-341492022-12-09
04716770931005INCENTIVE SPIROMETER,600/900/1200MLTB-931002016-09-06
04716770932507INCENTIVE SPIROMETER,2500MLTB-932502016-09-06
04716770932514 INCENTIVE SPIROMETERTB-932512017-12-15
04716770935003 INCENTIVE SPIROMETER,5000MLTB-935002016-09-06
04716770935010 INCENTIVE SPIROMETERTB-935012017-12-15
04716770790015Elbow connetor 18MM ID for nebulizerMP-790012017-12-13
04716770791043MOUTH PIECE (OD:18mm,22mm)MP-791042017-12-13

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