FDA UDI In Commercial Distribution 🇺🇸 United States

Equate

DI: 00194346135219 · Model: MD300CN510 · WAL-MART STORES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1

Basic Information

Brand Name
Equate
Primary DI
00194346135219
Version / Model
MD300CN510
Company Name
WAL-MART STORES, INC.
Labeler DUNS
051957769
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-09-13
Public Version
1
Public Version Date
2023-09-21
Public Version Status
New
Public Device Record Key
67a3aa23-a447-4b56-a2a3-c5cd9289e97c

Device Description

Pulse Oximeter with technology based on skin pigmentation

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
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
Yes
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
OCH Oximeter, Infrared, Sporting, Aviation

GMDN Terms

Code Name
45607 Pulse oximeter

Identifiers

Type ID
Package 10194346135216
Primary 00194346135219
Package 20194346135213