Adapter, Tube, Sample Pack 113300

GUDID 00817081027686

Adapter, Tube, Sample Pack, 1134, 1135, 1136, 1138

A-M SYSTEMS, LLC

Breathing mouthpiece, reusable
Primary Device ID00817081027686
NIH Device Record Keyad117574-bb9b-469b-b529-b4c854efe2e6
Commercial Distribution StatusIn Commercial Distribution
Brand NameAdapter, Tube, Sample Pack
Version Model NumberAdapter, Tube, Sample Pack - 113300
Catalog Number113300
Company DUNS020275145
Company NameA-M SYSTEMS, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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
GS100817081027686 [Primary]

FDA Product Code

BYPMouthpiece, Breathing

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-29
Device Publish Date2023-11-21

Devices Manufactured by A-M SYSTEMS, LLC

00817081027914 - 3 Liter Aluminum Calibration Syringe w/ Adapter2024-11-15 3 Liter Aluminum Calibration Syringe w/ Adapter
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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