FDA UDI In Commercial Distribution 🇺🇸 United States

AnaVue 4000 Patient Monitor

DI: 05051977000666 · Model: AnaVue 4000 · PENLON LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
AnaVue 4000 Patient Monitor
Primary DI
05051977000666
Version / Model
AnaVue 4000
Catalog Number
5005240
Company Name
PENLON LTD
Labeler DUNS
458942687
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-02-05
Public Version
3
Public Version Date
2021-11-10
Public Version Status
Update
Public Device Record Key
64f65310-9795-47e9-8989-66bcb5d17b95

Device Description

Patient Monitor

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

GMDN Terms

Code Name
33586 General-purpose multi-parameter bedside monitor

Identifiers

Type ID
Primary 05051977000666