Pneupac

GUDID 10610586046063

Smiths Medical International Ltd

Ventilator breathing circuit, single-use
Primary Device ID10610586046063
NIH Device Record Keyefa590fa-7d27-45e8-9f2b-d2c2bdce9064
Commercial Distribution StatusIn Commercial Distribution
Brand NamePneupac
Version Model Number122003
Company DUNS215590304
Company NameSmiths Medical International Ltd
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

Device Identifiers

Device Issuing AgencyDevice ID
GS110610586046063 [Primary]
GS130610586046067 [Package]
Package: BAG [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BTLVentilator, emergency, powered (resuscitator)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-27
Device Publish Date2015-10-12

On-Brand Devices [Pneupac]

35019315107478530A1167
35019315107270P300NUS
35019315107263P310NUS
35019315074862VR1AIRNUS
35019315074183V200DNUS
35019315072738P200DNUS
35019315071892B100NUS
35019315071533APH
35019517160219100/905/340-CH
35019517159602100/905/301-CH
35019517159121100/905/300-CH
45019315079215100/905/361
45019315079208100/905/360
35019315076118100/905/341
35019315076101100/905/340
35019517160226100/905/341-CH
10610586046063122003
10610586046056122002

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