Respiratory Mechanics Flow Sensor – Adult/Pediatri

GUDID 04049098007740

DRAEGER MEDICAL SYSTEMS, INC.

Breathing circuit gas-flow sensor, reusable Carbon dioxide cuvette, single-use Carbon dioxide cuvette, single-use Carbon dioxide cuvette, single-use Carbon dioxide cuvette, single-use Carbon dioxide cuvette, single-use Carbon dioxide cuvette, single-use Carbon dioxide cuvette, single-use Carbon dioxide cuvette, single-use Carbon dioxide cuvette, single-use Carbon dioxide cuvette, single-use Carbon dioxide cuvette, single-use Carbon dioxide cuvette, single-use Carbon dioxide cuvette, single-use Carbon dioxide cuvette, single-use Carbon dioxide cuvette, single-use Carbon dioxide cuvette, single-use Carbon dioxide cuvette, single-use
Primary Device ID04049098007740
NIH Device Record Keycfc58d06-c895-4c93-8c3f-1feb54a63840
Commercial Distribution StatusIn Commercial Distribution
Brand NameRespiratory Mechanics Flow Sensor – Adult/Pediatri
Version Model Number5957134
Company DUNS788289952
Company NameDRAEGER MEDICAL SYSTEMS, INC.
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 Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+18004372437
Emailinfo@draeger.com
Phone+18004372437
Emailinfo@draeger.com
Phone+18004372437
Emailinfo@draeger.com
Phone+18004372437
Emailinfo@draeger.com
Phone+18004372437
Emailinfo@draeger.com
Phone+18004372437
Emailinfo@draeger.com
Phone+18004372437
Emailinfo@draeger.com
Phone+18004372437
Emailinfo@draeger.com
Phone+18004372437
Emailinfo@draeger.com
Phone+18004372437
Emailinfo@draeger.com
Phone+18004372437
Emailinfo@draeger.com
Phone+18004372437
Emailinfo@draeger.com
Phone+18004372437
Emailinfo@draeger.com
Phone+18004372437
Emailinfo@draeger.com
Phone+18004372437
Emailinfo@draeger.com
Phone+18004372437
Emailinfo@draeger.com
Phone+18004372437
Emailinfo@draeger.com
Phone+18004372437
Emailinfo@draeger.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104049098007740 [Primary]

FDA Product Code

BXPTransducer, Gas Flow

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2015-11-02

Devices Manufactured by DRAEGER MEDICAL SYSTEMS, INC.

04049098099042 - Babyroo TN300 Infant Radiant Warmer2023-06-16
04049098002035 - INFINITY M300 Nellcor WPA2 2020-02-06
04049098002066 - Infinity M300 Masimo WPA2 2020-02-06
04049098002172 - Omega-S Solution2020-02-06
04049098003858 - Infinity Vista XL Monitor2020-02-06
04049098003865 - INFINITY GAMMMA XL2020-02-06
04049098004022 - Vista Monitor2020-02-06
04049098004039 - Infinity Kappa Monitor2020-02-06

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