AnaVue 4000 Patient Monitor 5005240

GUDID 05051977000666

Patient Monitor

PENLON LTD

Single-patient intensive/general healthcare physiologic monitoring system
Primary Device ID05051977000666
NIH Device Record Key64f65310-9795-47e9-8989-66bcb5d17b95
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnaVue 4000 Patient Monitor
Version Model NumberAnaVue 4000
Catalog Number5005240
Company DUNS458942687
Company NamePENLON LTD
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 Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105051977000666 [Primary]

FDA Product Code

MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-13
Device Publish Date2020-02-05

Devices Manufactured by PENLON LTD

05051977000857 - Penlon2024-12-16
05051977001465 - Penlon2024-12-16 Sigma Delta Vaporizer / Halothane
05051977002011 - Penlon2024-12-16 Sigma Delta Vaporizer / Isoflurane
05051977002028 - Penlon2024-12-16 Sigma Delta Vaporizer / Sevoflurane
05051977002035 - Penlon2024-12-16 Sigma Delta MRI Vaporizer / Sevoflurane
05051977002042 - Penlon2024-12-16 Sigma Delta MRI Vaporizer / Isoflurane
05051977003599 - Penlon2024-12-16 MRI STAND HANDLE
05051977003605 - Penlon2024-12-16 HANDLE SHORT MRI

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