FDA.reportPublic FDA data

Venti.Plus

Primary DI
04710810100284
Brand
Venti.Plus
Company
GaleMed Xiamen Co., Ltd.
Model
5407
Catalog number
H100-HD
Device description
1.0 HYPERINFLATION W/ MANOMETER
Published
2015-09-19
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
44710810100282PackageGS120In Commercial Distribution
04710810100284PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
4471081010028244710810100282
04710810100284047108101002844710810100284

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia breathing circuit, single-useAn assembly of devices designed to conduct medical gases from an anaesthesia unit/workstation to a patient artificial airway/anaesthesia mask (not included) during general anaesthesia. It includes breathing tubes and a Y-piece connector, typically with a ventilator/ventilation bag and appropriate connectors, and may include a carbon dioxide (CO2) absorber, a one-way directional valve, or adjustable pressure limiting (APL) valve. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-30 Degrees Celsius50 Degrees Celsius

Regulatory Flags#

DUNS number
527333326
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06923980111907MindrayXMR00512026-05-26
06923980112546MindrayXMR00662026-05-26
06923980112577MindrayXMR00242026-05-26
06923980112584MindrayXMR00262026-05-26
06923980112591MindrayXMR01012026-05-26
06923980112607MindrayXMR01022026-05-26
06923980112614MindrayXMR00522026-05-26
06923980112621MindrayXMR00532026-05-26
06923980112638MindrayXMR00812026-05-26
06923980112690MindrayXMR01042026-05-26
06923980112799MindrayXMR00582026-05-26
06923980112805MindrayXMR00442026-05-26
06923980112829MindrayXMR00462026-05-26
06944904007236MindrayXMR00862026-05-26
16923980111843MindrayXMR02302026-05-26
06923980112522MindrayXMR00112026-05-25
06923980112539MindrayXMR00122026-05-25
06923980112553MindrayXMR00212026-05-25
06923980112560MindrayXMR00232026-05-25
06923980112645MindrayXMR00152026-05-25

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