PFT Kit B, 33 MM O.D. W/ White Foam Nose Clip 183112

GUDID 00817081027679

Pulmonary Function Testing Kit B, Disposable, Qty 100, 33 MM O.D. W/ White Foam Nose Clip

A-M SYSTEMS, LLC

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Primary Device ID00817081027679
NIH Device Record Key632ebaf5-e205-4461-9dd2-0a8f337b2d68
Commercial Distribution StatusIn Commercial Distribution
Brand NamePFT Kit B, 33 MM O.D. W/ White Foam Nose Clip
Version Model NumberPFT Kit B, 33 MM O.D. W/ White Foam Nose Clip - 18
Catalog Number183112
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
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
GS100817081027662 [Primary]
GS100817081027679 [Package]
Contains: 00817081027662
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 Date2023-10-25
Device Publish Date2023-10-17

Devices Manufactured by A-M SYSTEMS, LLC

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00817081027723 - PFT KIT A, 31 MM O.D. w/ White Foam Nose Clips2024-03-25 Pulmonary Function Test KIT A, 31 MM O.D. w/ White Foam Nose Clips
00817081027686 - Adapter, Tube, Sample Pack2023-11-29 Adapter, Tube, Sample Pack, 1134, 1135, 1136, 1138
00817081027679 - PFT Kit B, 33 MM O.D. W/ White Foam Nose Clip2023-10-25Pulmonary Function Testing Kit B, Disposable, Qty 100, 33 MM O.D. W/ White Foam Nose Clip
00817081027679 - PFT Kit B, 33 MM O.D. W/ White Foam Nose Clip2023-10-25 Pulmonary Function Testing Kit B, Disposable, Qty 100, 33 MM O.D. W/ White Foam Nose Clip
00817081027655 - PFT Kit E, VBMax31E, with Rubber Mouthpiece & Noseclip2023-10-12 PFT Kit E, VBMax31E, with Rubber Mouthpiece & Noseclip
00817081027624 - PFT Kit G, VBMax 34E2023-06-29 Pulmonary Function Test Kit G, Disposable, Qty 100, VBMax34E with Disposable Rubber Mouthpiece
00817081027600 - Personal Best Full Range Peak Flow Meter2023-06-15 Personal Best Full Range Peak Flow Meter
00817081027587 - PFT Kit I, VBMax31S2023-05-25 Pulmonary Function Test Kit I, VBMax31S, with White Foam Nose Clip & Rubber Mouthpiece

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