989803144701

GUDID 20884838072224

Philips Medizin Systeme Böblingen GmbH

Monitoring spirometer, electrical
Primary Device ID20884838072224
NIH Device Record Key141e971d-c610-41bf-a278-675446da862d
Commercial Distribution StatusIn Commercial Distribution
Version Model Number989803144701
Catalog Number989803144701
Company DUNS314101143
Company NamePhilips Medizin Systeme Böblingen GmbH
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(999)999-9999
Emailxx@xx.xx
Phone+1(999)999-9999
Emailxx@xx.xx
Phone+1(999)999-9999
Emailxx@xx.xx
Phone+1(999)999-9999
Emailxx@xx.xx
Phone+1(999)999-9999
Emailxx@xx.xx
Phone+1(999)999-9999
Emailxx@xx.xx
Phone+1(999)999-9999
Emailxx@xx.xx
Phone+1(999)999-9999
Emailxx@xx.xx
Phone+1(999)999-9999
Emailxx@xx.xx
Phone+1(999)999-9999
Emailxx@xx.xx
Phone+1(999)999-9999
Emailxx@xx.xx
Phone+1(999)999-9999
Emailxx@xx.xx
Phone+1(999)999-9999
Emailxx@xx.xx
Phone+1(999)999-9999
Emailxx@xx.xx
Phone+1(999)999-9999
Emailxx@xx.xx
Phone+1(999)999-9999
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS120884838072224 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MHXMONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-01-20

Devices Manufactured by Philips Medizin Systeme Böblingen GmbH

00884838117440 - NOUN2025-08-29 36" patient cable (standard), for use only with the DigiTrak XT recorder
00884838120303 - MR Patient Care Universal Gating Interface2025-08-01 Gating cable for use between any Expression MR patient monitor and any wired or wireless MRI system accessories.
00884838126411 - Leads2025-07-24 Wireless PIM Leadwires for PageWriter TC Series Cardiographs, 10-lead, AAMI color-coding, 3mm needle
00884838126428 - Leads2025-07-24 Wireless PIM Leadwires for PageWriter TC Series Cardiographs,10-lead, IEC color-coding, 4mm banana
00884838114937 - NIBP Cuffs2025-07-11 Neonatal Soft Single-Patient Cuff Size#2
00884838114951 - NIBP Cuffs2025-07-11 Neonatal Soft Single-Patient Cuff Size#2
00884838114975 - NIBP Cuffs2025-07-11 Neonatal Soft Single-Patient Cuff Size#2
00884838114999 - NIBP Cuffs2025-07-11 Neonatal Soft Single-Patient Cuff Size#2

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.