VT Select

GUDID 10841470100794

PULMODYNE INC

Pulmonary resuscitator, manual, single-use
Primary Device ID10841470100794
NIH Device Record Key9e1b0865-5c01-4d5c-8d5c-d7329df4af8c
Commercial Distribution StatusIn Commercial Distribution
Brand NameVT Select
Version Model Number313-5593
Company DUNS030619483
Company NamePULMODYNE INC
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

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Device Identifiers

Device Issuing AgencyDevice ID
GS100841470100797 [Primary]
GS110841470100794 [Package]
Contains: 00841470100797
Package: [8 Units]
In Commercial Distribution

FDA Product Code

BTMVentilator, Emergency, Manual (Resuscitator)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-04-18
Device Publish Date2023-04-10

On-Brand Devices [VT Select]

10841470100817313-5594
10841470100794313-5593
10841470100770313-5591
10841470100749313-5592
10841470100718313-5590

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