Pulmonary Function Test Kit F 189174

GUDID 00817081027426

Pulmonary Function Test Kit F, Disposable, VBMax34E w/ Blue Rubber Nose Clips

A-M SYSTEMS, LLC

Pulmonary function testing kit
Primary Device ID00817081027426
NIH Device Record Key60b81ae0-f5b0-4783-8823-eeae53ab6097
Commercial Distribution StatusIn Commercial Distribution
Brand NamePulmonary Function Test Kit F
Version Model NumberPulmonary Function Test Kit F, 189174
Catalog Number189174
Company DUNS020275145
Company NameA-M SYSTEMS, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone3606838300
Emailsales@a-msystems.com
Phone3606838300
Emailsales@a-msystems.com
Phone3606838300
Emailsales@a-msystems.com
Phone3606838300
Emailsales@a-msystems.com
Phone3606838300
Emailsales@a-msystems.com
Phone3606838300
Emailsales@a-msystems.com
Phone3606838300
Emailsales@a-msystems.com
Phone3606838300
Emailsales@a-msystems.com
Phone3606838300
Emailsales@a-msystems.com
Phone3606838300
Emailsales@a-msystems.com
Phone3606838300
Emailsales@a-msystems.com
Phone3606838300
Emailsales@a-msystems.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100817081027419 [Primary]
GS100817081027426 [Package]
Contains: 00817081027419
Package: [100 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CAHFilter, Bacterial, Breathing-Circuit

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-09
Device Publish Date2022-12-01

Devices Manufactured by A-M SYSTEMS, LLC

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00817081027884 - PFT Kit A, 28MM O.D2024-11-01 Pulmonary Function Test Kit A, 28MM O.D., W/Foam Nose Clip & Rubber Mouthpiece
00817081027907 - PFT Kit J, VBMax36S2024-11-01 Pulmonary Function Test Kit J, VBMax36S with Blue Foam Nose Clip
00817081027846 - PFT Kit I, VBMax 34s with Nose Clip and Mouthpiece2024-10-16 Pulmonary Function Test Kit I, VBMax34S, w/ Blue Rubber Nose Clips & Rubber Mouthpiece
00817081027860 - PFT KIT J, VBMax35S, w/ Foam Nose Clip2024-10-16 Pulmonary Function Test Kit J, VBMax35S, w/ Foam Nose Clip
00817081027822 - PFT Kit A, 48 MM O.D.2024-09-30 PFT Kit A, 48 MM O.D.
00817081027808 - PFT KIT F, VBMax36S w/ Rubber Nose Clips2024-09-16 Pulmonary Function Test Kit F, VBMax36S with Rubber Nose Clips
00817081027785 - PFT Kit I, VBMax35S, w/ White Foam Nose Clips2024-07-18 Pulmonary Function Test Kit I, VBMax35S, w/ White Foam Nose Clips

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