FDA UDI In Commercial Distribution 🇺🇸 United States

RD rainbow SET-2

DI: 10843997010907 · Model: 4026 · MASIMO CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10

Basic Information

Brand Name
RD rainbow SET-2
Primary DI
10843997010907
Version / Model
4026
Company Name
MASIMO CORPORATION
Labeler DUNS
780421038
Distribution Status
In Commercial Distribution
Device Count in Pkg
10
Record Status
Published
Publish Date
2020-09-03
Public Version
1
Public Version Date
2020-09-11
Public Version Status
New
Public Device Record Key
fa40eb3a-2340-4acf-9fb4-d588e26cd6c9

Device Description

RD rainbow SET-2 Adult Pulse CO-Oximeter Adhesive Sensor

Device Characteristics

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

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
DQA Oximeter

GMDN Terms

Code Name
47581 Pulse Co-oximeter probe, single-use

Identifiers

Type ID
Unit of Use 00843997010900
Primary 10843997010907

Customer Contacts