Pneupac

GUDID 10610586045516

SMITHS MEDICAL MD, INC.

Ventilator breathing circuit, single-use
Primary Device ID10610586045516
NIH Device Record Key7d83fbb2-f59d-4752-ad1b-802a2dbb7918
Commercial Distribution StatusIn Commercial Distribution
Brand NamePneupac
Version Model Number122203
Company DUNS106712748
Company NameSMITHS MEDICAL MD, 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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110610586045516 [Primary]

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 Number5
Public Version Date2019-11-27
Device Publish Date2015-09-01

On-Brand Devices [Pneupac]

30610586045749WW122006
30610586045558124003
10610586045547123004
10610586045530123001
10610586045523123000
10610586045516122203
10610586045509122202
30610586038284122004

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