Optichamber Diamond w/ Small, Lite Touch VHC Mask 166402

GUDID 00817081026603

Valved Holding Chamber, Optichamber Diamond w/ Small, Lite Touch VHC Mask

A-M SYSTEMS, LLC

Medicine chamber spacer, reusable
Primary Device ID00817081026603
NIH Device Record Key841bcc3f-8f6d-4716-a5bb-b476a763d71e
Commercial Distribution StatusIn Commercial Distribution
Brand NameOptichamber Diamond w/ Small, Lite Touch VHC Mask
Version Model NumberOptichamber Diamond w/ Small, Lite Touch VHC Mask
Catalog Number166402
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone3606838300
Emailsales@a-msystems.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100817081026603 [Primary]

FDA Product Code

NVPHolding Chambers, Direct Patient Interface

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-21
Device Publish Date2020-04-13

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.