PFM

GUDID 55099169439813

4300 PEAK FLOW METER

VITALOGRAPH (IRELAND) LIMITED

Peak flow meter, manual
Primary Device ID55099169439813
NIH Device Record Keyd676a0f4-fbf8-4d13-b5d4-5e80ddafc23c
Commercial Distribution StatusIn Commercial Distribution
Brand NamePFM
Version Model Number4300
Company DUNS219683489
Company NameVITALOGRAPH (IRELAND) LIMITED
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS105099169439818 [Primary]
GS135099169439819 [Package]
Contains: 05099169439818
Package: [25 Units]
In Commercial Distribution
GS155099169439813 [Package]
Contains: 35099169439819
Package: [40 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BZHMETER, PEAK FLOW, SPIROMETRY

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-12-09

On-Brand Devices [PFM]

350991694399704300 PEAK FLOW METER myPEF
350991694399324300 PEAK FLOW METER myPEF
350991694399184300 PEAK FLOW METER
350991694398404300 PEAK FLOW METER myPEF
350991694398334300 PEAK FLOW METER myPEF SWITZERLAND
550991694398134300 PEAK FLOW METER
55099169439509my PEF PEAK FLOW METER
550991694390354300 PEAK FLOW METER myPEF UNIVERSAL DE (NON WEB)
550991694390044300 PEAK FLOW METER myPEF (NON WEB)
350991694382184300 PEAK FLOW METER ADULT
350991694370374300 PEAK FLOW METER CHILD
350991694360234300 PEAK FLOW METER
350991694340054300 PEAK FLOW METER GERMAN
550991694300014300 PEAK FLOW METER C/W CARTON GERMAN
550991694391104300 PEAK FLOW METER

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