FDA UDI In Commercial Distribution 🇺🇸 United States

Easy@Home Fingertip Pulse Oximeter

DI: 00810038631080 · Model: EHP029 · EASY HEALTHCARE CORPORATION
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
Easy@Home Fingertip Pulse Oximeter
Primary DI
00810038631080
Version / Model
EHP029
Company Name
EASY HEALTHCARE CORPORATION
Labeler DUNS
080278407
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-08-10
Public Version
2
Public Version Date
2021-11-10
Public Version Status
Update
Public Device Record Key
9921ab7e-1378-40ef-87c0-6fbb10719878

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
Yes
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
DQA Oximeter
OCH Oximeter, Infrared, Sporting, Aviation

GMDN Terms

Code Name
45607 Pulse oximeter

Identifiers

Type ID
Package 10810038631087
Primary 00810038631080