PFT Kit I 187126

GUDID 00817081026689

PFT Kit I, Disposable, VBMax 36S, w/ White Foam Noseclips

A-M SYSTEMS, LLC

Pulmonary function testing kit Pulmonary function testing kit Pulmonary function testing kit
Primary Device ID00817081026689
NIH Device Record Keyfcf28fe4-355e-4f69-a5d4-4ef6e420eeec
Commercial Distribution StatusIn Commercial Distribution
Brand NamePFT Kit I
Version Model NumberPFT Kit I, VBMax 36S, w/ White Foam Noseclips - 18
Catalog Number187126
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100817081026672 [Primary]
GS100817081026672 [Primary]
GS100817081026672 [Primary]
GS100817081026689 [Package]
Contains: 00817081026672
Package: [100 Units]
In Commercial Distribution
GS100817081026689 [Package]
Contains: 00817081026672
Package: [100 Units]
In Commercial Distribution
GS100817081026689 [Package]
Contains: 00817081026672
Package: [100 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CAHFilter, Bacterial, Breathing-Circuit
CAHFilter, Bacterial, Breathing-Circuit
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 Date2020-05-19
Device Publish Date2020-05-11

Devices Manufactured by A-M SYSTEMS, LLC

00817081026689 - PFT Kit I2020-05-19PFT Kit I, Disposable, VBMax 36S, w/ White Foam Noseclips
00817081026689 - PFT Kit I2020-05-19 PFT Kit I, Disposable, VBMax 36S, w/ White Foam Noseclips
00817081026665 - PFT Kit A, Disposable, 48MM OD2020-05-14 PFT Kit A, Disposable, 48MM OD Filter w/ Blue Foam Nose Clip and Rubber Mouthpiece
00817081026641 - Syringe, Calibration, 3 Liter, Aluminum, Eliptical Cap2020-04-22 Syringe, Calibration, 3 Liter, Aluminum, Eliptical Cap
00817081026597 - Optichamber Diamond2020-04-21 Valved Holding Chamber, Optichamber Diamond
00817081026603 - Optichamber Diamond w/ Small, Lite Touch VHC Mask2020-04-21 Valved Holding Chamber, Optichamber Diamond w/ Small, Lite Touch VHC Mask
00817081026610 - Optichamber Diamond w/ Medium, Lite Touch VHC Mask2020-04-21 Valved Holding Chamber, Optichamber Diamond w/ Medium, Lite Touch VHC Mask
00817081026399 - Nebulizer, Hand Held, Tee Adapter2020-04-20 Nebulizer, Hand Held, Tee Adapter, 84" Tube, 5" Tube
00817081026412 - Nebulizer, Hand Held2020-04-20 Nebulizer, Hand Held

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