PFT

GUDID 05099169284265

2820 PFT KIT 25ID

VITALOGRAPH (IRELAND) LIMITED

Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use
Primary Device ID05099169284265
NIH Device Record Keyc2eb6ca2-2ec0-42bc-a175-b2c8f17fe12e
Commercial Distribution StatusIn Commercial Distribution
Brand NamePFT
Version Model Number2820
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
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 TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105099169284265 [Package]
Contains: 15099169284262
Package: [50 Units]
In Commercial Distribution
GS115099169284262 [Primary]
GS155099169284260 [Package]
Package: [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BZGSPIROMETER, DIAGNOSTIC

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-03-23
Device Publish Date2016-12-01

On-Brand Devices [PFT]

550991692857312820 ECO PFT KIT MS
050991692857292820 Eco BVF + DNC
050991692857122820 Eco BVF LAB + DNC
050991692855212820 ECO BVF LAB
050991692855072820 ECO BVF
550991692844992820 BVF (28401) + DNC
050991692844872820 BVF (FOSTER) + DNC + OVAL MP
050991692844322820 BVF (KOKO) + DNC + FRONT BITE-ON
050991692844252820 BVF (MED GR) + DNC + FRONT BITE-ON
550991692844132820 BVF (JAE) + DNC + FRONT BITE-ON
050991692844012820 BVF (SM,PKM,Ga) + DNC + FRONT BITE
050991692843952820 BVF(28365) + 2020 REAR BITE-ON + 2030 DISP NOSE CLIP
050991692843882820 BVF (28365) + 2030 DISP NOSE CLIP + OVAL MP
050991692843712820 BVF (28368) + OVAL MOUTHPIECE
550991692843692820 BVF (28368) + 2030 NOSE CLIP
050991692843402820 PFT KIT
0509916928432630/30 PFT KIT
050991692843192820 BVF (28362) + OVAL M/P + 2030 DISPOSABLE NOSE CLIP
050991692843022820 BVF (28365) + OVAL M/P
050991692842962820 BVF (28363) + OVAL M/P
050991692842892820 BVF (28362) + OVAL M/P
550991692842772820 BVF (28350) + OVAL M/P
050991692842652820 PFT KIT 25ID
050991692842582820 PFT KIT TRANSL. BVF FRONT-BITE
550991692842152820 PFT KIT 30/30
050991692841802820 PFT KIT 30ID MEDISIZE
550991692840482820 BV FILTER + OVAL M/P + 2030 NOSECLIP
550991692840312820 BV FILTER (28363) + OVAL M/P + 2030 NOSE CLIP
050991692840292820 BV FILTER (28350) + OVAL M/P + 2030 NOSE CLIP
0509916928400530/30 PFT KIT
050991692838552820 BV FILTER(28363)+OVAL M/P+45 ELBOW+2030 NOSE CLIP
050991692838242820 BVF PFT KIT 28363
550991692838122820 BV FILTER + 2030 NOSE CLIPS PFT KIT (28362)
050991692837252820 BV FILTER + 2030 NOSE CLIPS (28362 + 20243)
550991692837132820 BV FILTER + 2030 NOSE CLIPS (28363 + 20243)
050991692837012820 BV FILTER + 2030 NOSE CLIPS (28350 + 20243)
550991692855332820 ECO BVF WITH BITE LIP + DNC
050991692855142820 ECO BVF + BITE-ON MOUTHPIECE +DNC

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