CAIRE Diagnostics 900-0019-50

GUDID 00860008017956

Box of 50 Fenom Pro Mouthpieces, PN 810-0006 Sold in box of 50 only, individual mouthpieces are not for retail or commercial sale Each mouthpiece is individually packaged

Caire Diagnostics Inc.

Diagnostic spirometer
Primary Device ID00860008017956
NIH Device Record Keyebd7ecef-d3ec-46ed-abdd-f6618ae27047
Commercial Distribution StatusIn Commercial Distribution
Brand NameCAIRE Diagnostics
Version Model NumberFenom Pro Mouthpieces, Box of 50
Catalog Number900-0019-50
Company DUNS117548764
Company NameCaire Diagnostics Inc.
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100860008017956 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MXASystem, Test, Breath Nitric Oxide

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-02-08
Device Publish Date2022-01-31

On-Brand Devices [CAIRE Diagnostics]

00860008017956Box of 50 Fenom Pro Mouthpieces, PN 810-0006 Sold in box of 50 only, individual mouthpieces are
00860008017949Package contains: Fenom Pro Device - P/N 900-0001, GTIN 00860008017901 Configured for Australia/
00860008017932Package contains: Fenom Pro Device - P/N 900-0001, GTIN 00860008017901 Configured as a Demo Unit
00860008017925Package contains: Fenom Pro Device - P/N 900-0001, GTIN 00860008017901 Configured for EU Instruc
00860008017918Package contains: Fenom Pro Device - P/N 900-0001, GTIN 00860008017901 Configured for US Instruc
00860008017901Package contains: External Power Supply, P/N 197-0001 Instructions for Use Reference, Fenom Pro

Trademark Results [CAIRE Diagnostics]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CAIRE DIAGNOSTICS
CAIRE DIAGNOSTICS
90132307 not registered Live/Pending
CAIRE INC.
2020-08-24

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