PFT Kit A, 48 MM O.D. 188101

GUDID 00817081027822

PFT Kit A, 48 MM O.D.

A-M SYSTEMS, LLC

Pulmonary function testing kit
Primary Device ID00817081027822
NIH Device Record Keyf8e7918b-362a-42d3-aa27-0a508b42a5ba
Commercial Distribution StatusIn Commercial Distribution
Brand NamePFT Kit A, 48 MM O.D.
Version Model NumberPFT Kit A, 48 MM O.D. - 188101
Catalog Number188101
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 Kitfalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100817081027815 [Primary]
GS100817081027822 [Package]
Contains: 00817081027815
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 Date2024-09-30
Device Publish Date2024-09-20

Devices Manufactured by A-M SYSTEMS, LLC

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.2024-09-30PFT Kit A, 48 MM O.D.
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
00817081027761 - Pulmonary Function Test Kit J, VBMax30S2024-07-10 Pulmonary Function Test Kit J, VBMax30S
00817081027747 - PFT KIT F, 31 MM, e-Series, / Blue Foam Nose Clips2024-07-04 Pulmonary Function Test Kit F, 31 MM O.D., e-Series, / Blue Foam Nose Clips
00817081027709 - Pulmonary Function Test Kit B, 33mm VBMAX2024-03-25 Pulmonary Function Test Kit B, Disposable, Qty 100, 33 MM O.D. W/ Blue Foam Nose Clip

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