Ventlanb

GUDID 20889483081164

PEDIATRIC RESUS W/MANOMETER, POP-OFF & 2 MASKS

VENTLAB, LLC

Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use
Primary Device ID20889483081164
NIH Device Record Key8ae62bc7-22df-40b8-a3d4-4541299e668d
Commercial Distribution StatusIn Commercial Distribution
Brand NameVentlanb
Version Model NumberAF2142MB-2
Company DUNS038305402
Company NameVENTLAB, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-433-2797
Emailinfo@sun-med.com
Phone800-433-2797
Emailinfo@sun-med.com
Phone800-433-2797
Emailinfo@sun-med.com
Phone800-433-2797
Emailinfo@sun-med.com
Phone800-433-2797
Emailinfo@sun-med.com
Phone800-433-2797
Emailinfo@sun-med.com
Phone800-433-2797
Emailinfo@sun-med.com
Phone800-433-2797
Emailinfo@sun-med.com
Phone800-433-2797
Emailinfo@sun-med.com
Phone800-433-2797
Emailinfo@sun-med.com
Phone800-433-2797
Emailinfo@sun-med.com
Phone800-433-2797
Emailinfo@sun-med.com
Phone800-433-2797
Emailinfo@sun-med.com
Phone800-433-2797
Emailinfo@sun-med.com
Phone800-433-2797
Emailinfo@sun-med.com

Device Dimensions

Total Volume1000 Milliliter
Total Volume1000 Milliliter
Total Volume1000 Milliliter
Total Volume1000 Milliliter
Total Volume1000 Milliliter
Total Volume1000 Milliliter
Total Volume1000 Milliliter
Total Volume1000 Milliliter
Total Volume1000 Milliliter
Total Volume1000 Milliliter
Total Volume1000 Milliliter
Total Volume1000 Milliliter
Total Volume1000 Milliliter
Total Volume1000 Milliliter
Total Volume1000 Milliliter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Do not get wet.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Do not get wet.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Do not get wet.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Do not get wet.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Do not get wet.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Do not get wet.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Do not get wet.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Do not get wet.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Do not get wet.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Do not get wet.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Do not get wet.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Do not get wet.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Do not get wet.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Do not get wet.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Do not get wet.

Device Identifiers

Device Issuing AgencyDevice ID
GS110889483081167 [Primary]
GS120889483081164 [Package]
Contains: 10889483081167
Package: Box [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BTMVentilator, Emergency, Manual (Resuscitator)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-10-21
Device Publish Date2016-11-16

Devices Manufactured by VENTLAB, LLC

10889483555675 - Ventlab2024-03-20 AirFlow Pediatric Resuscitator with Integrated Manometer, B/V Filter, 40cm Pop-Off, Bag Reservoir, Gas Sampling Line, and Size 5
10889483555682 - Ventlab2024-03-20 AirFlow Adult Resuscitator with Bag Reservoir, Gas Sampling Line, and Mask
10889483555699 - Ventlab2024-03-20 AirFlow Adult Resuscitator with B/V Filter, Bag Reservoir, Gas Sampling Line, and Mask
10889483555705 - Ventlab2024-03-20 AirFlow Adult Resuscitator with B/V Filter, Bag Reservoir, Mask, PEEP Valve, and Gas Sampling Line
10889483555712 - Ventlab2024-03-20 AirFlow Adult Resuscitator with Integrated Manometer, B/V Filter, Bag Reservoir, Gas Sampling Line, and Mask
10889483555729 - Ventlab2024-03-20 AirFlow Adult Resuscitator with Integrated Manometer, B/V Filter, Bag Reservoir, Mask, PEEP Valve, and Gas Sampling Line
10889483555736 - Ventlab2024-03-20 AirFlow Adult Resuscitator with Integrated Manometer, B/V Filter, 40cm Pop-Off, Bag Reservoir, Mask, PEEP Valve, and Gas Samplin
10889483555743 - Ventlab2024-03-20 AirFlow Pediatric Resuscitator with Bag Reservoir, Gas Sampling Line, and Mask
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