FDA.reportPublic FDA data

Venti.Plus

Primary DI
04710810100499
Brand
Venti.Plus
Company
GALEMED CORPORATION
Model
H050-M
Catalog number
Hyperinflation System 0.5L with Mask
Published
2015-09-24
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
NHKResuscitator,Manual,Non Self-Inflating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHKResuscitator, Manual, Non Self-InflatingAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K092687000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092687000VENTI.PLUS HYPERINFLATION BAG SYSTEM WITH PRESSURE MANOMETERA Plus Medical2009-11-23NHK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
44710810100497PackageGS110In Commercial Distribution
04710810100499PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
4471081010049744710810100497
04710810100499047108101004994710810100499

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia face mask, reusableA flexible, form-shaped device designed to be placed over a patient's nose and/or mouth to direct anaesthetic gases to the upper airway. It is made of conductive or non-conductive rubber, polyvinyl chloride (PVC), or other sterilizable materials that produce a soft, flexible cover to create an airtight seal against the patient's face. It typically includes a 22 mm connector (adult) or a 15 mm connector (paediatric), and is available in a range of sizes. It may be stabilized with a headstrap. This device is sometimes used in association with a manual resuscitator. This is a reusable device.

Regulatory Flags#

DUNS number
656854379
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04710810085550N/A71053AB01252026-03-05
24710810110171N/A5428AM00342026-03-05
24710810112458N/A5429AM00352026-03-05
04710810080586N/A3564AD00492026-03-05
04710810080838N/A5313AM00282026-03-05
04710810081781N/A5304AM00942026-03-05
04710810081811N/A5305AM00952026-03-05
04710810082122N/A3565AD00512026-03-05
04710810082252N/A5315AM00302026-03-05
04710810082269N/A5314AM00292026-03-05
04710810082405N/A5311AM00262026-03-05
04710810082412N/A5312AM00272026-03-05
04710810082429N/A5316AM00312026-03-05
04710810082481N/A5306AM00962026-03-05
04710810082962N/A3551AD00022026-03-05
04710810083327N/A74112AC00532026-03-05
04710810084621N/A2339AR00822026-03-05
04710810084669N/A2437AV00022026-03-05
04710810084850N/A75045AC01712026-03-05
04710810084942N/A0015AM00422026-03-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10641043568385NuFLO2 Hyperinflation SystemMERCURY ENTERPRISES, INC.NHK2020-10-16
10641043558706HyperinflationMERCURY ENTERPRISES, INC.NHK2020-06-04
10641043568491NuFLO2 Hyperinflation SystemMERCURY ENTERPRISES, INC.NHK2019-12-18
10641043568507NuFLO2 Hyperinflation SystemMERCURY ENTERPRISES, INC.NHK2019-12-18
10641043568460NuFLO2 Hyperinflation SystemMERCURY ENTERPRISES, INC.NHK2019-12-06
10641043568484NuFLO2 Hyperinflation SystemMERCURY ENTERPRISES, INC.NHK2019-12-06
10641043568477NuFLO2 Hyperinflation SystemMERCURY ENTERPRISES, INC.NHK2019-11-29
10641043558683Hyperinflation SystemMERCURY ENTERPRISES, INC.NHK2018-09-19
10641043558690Hyperinflation SystemMERCURY ENTERPRISES, INC.NHK2018-09-19
10641043553916Breathing BagMERCURY ENTERPRISES, INC.NHK2018-08-30
10641043553923Breathing BagMERCURY ENTERPRISES, INC.NHK2018-08-30
10641043553930Breathing BagMERCURY ENTERPRISES, INC.NHK2018-08-30
10641043553954Breathing BagMERCURY ENTERPRISES, INC.NHK2018-08-30
10641043558119Hyperinflation SystemMERCURY ENTERPRISES, INC.NHK2018-01-31
10641043558126Hyperinflation SystemMERCURY ENTERPRISES, INC.NHK2018-01-31
10641043558232Hyperinflation SystemMERCURY ENTERPRISES, INC.NHK2018-01-31
10641043558669Hyperinflation SystemMERCURY ENTERPRISES, INC.NHK2017-06-30
10641043568415NuFLO2 Hyperinflation SystemMERCURY ENTERPRISES, INC.NHK2017-06-14
10641043568392NuFLO2 Hyperinflation SystemMERCURY ENTERPRISES, INC.NHK2017-04-10
10641043568408NuFLO2 Hyperinflation SystemMERCURY ENTERPRISES, INC.NHK2017-04-10
10641043558638Hyperinflation SystemMERCURY ENTERPRISES, INC.NHK2017-04-08
10641043558645Hyperinflation SystemMERCURY ENTERPRISES, INC.NHK2017-04-08
10889483085356VentlabVENTLAB, LLCNHK2016-12-22
10889483085738VentlabVENTLAB, LLCNHK2016-12-22
10889483089408VentlabVENTLAB, LLCNHK2016-12-22
10889483075661VentlabVENTLAB, LLCNHK2016-12-21
10889483080986VentlabVENTLAB, LLCNHK2016-12-21
10889483082256VentlabVENTLAB, LLCNHK2016-12-21
10889483083475VentlabVENTLAB, LLCNHK2016-12-21
10889483084571VentlabVENTLAB, LLCNHK2016-12-21