FDA.reportPublic FDA data

Ventlab

Primary DI
10889483089408
Brand
Ventlab
Company
VENTLAB, LLC
Model
HS4151-MZ
Device description
.5 LITER HYPERINFLATION SYSTEM W/MANOMETER & MASK IN ZIP BAG
Published
2016-12-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NHKResuscitator,Manual,Non Self-Inflating

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20889483089405PackageGS110Not in Commercial Distribution
10889483089408PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088948308940520889483089405
1088948308940810889483089408

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume0.5Liter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperature. Do not get wet.

Contacts#

Phone, Email table
PhoneEmail
800-433-2797info@sun-med.com

Regulatory Flags#

DUNS number
038305402
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
10889483075494VentlabAF2140MB-N2016-11-16
10889483075876VentlabAF2000MB2016-11-14
10889483076019VentlabAF2100MB-32016-11-14
10889483076286VentlabAF2140MB-D42016-11-16
10889483077566VentlabAF2140MB-I2016-11-16
10889483077573Ventlab, LLCAF2140MB-PWAF2140MB-PW2023-06-26
10889483077931VentlabAF2142MB-32016-11-16
10889483078068VentlabAF2140MB2016-11-16
10889483078167VentlabAF2042MB2016-11-14
10889483078181VentlabAF2100MB-MMC2016-11-14
10889483081143VentlabAF2140MB-22016-11-16
10889483081150VentlabAF2140MB-K2016-11-16
10889483081167VentlanbAF2142MB-22016-11-16
10889483081181VentlabAF2142MC-32016-11-16
10889483085752VentlabAF2042MB-K2016-11-14
10889483085769VentlabAF2102MC-PT2016-11-14
10889483087787VentlabAF2140MB-32016-11-16
10889483088128VentlabAF2142MB-K2016-11-16
10889483089262VentlabAF2142OB2016-11-16
10889483090237VentlabAF2142MB2016-11-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10860015046014XChangePneuma Therapeutics, Inc.NHK2026-11-02
10889483481226Ventlab Hyperinflation SystemVENTLAB, LLCNHK2026-06-24
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
10889483075661VentlabVENTLAB, LLCNHK2016-12-21
10889483080986VentlabVENTLAB, LLCNHK2016-12-21
10889483082256VentlabVENTLAB, LLCNHK2016-12-21
10889483083475VentlabVENTLAB, LLCNHK2016-12-21