FDA UDI In Commercial Distribution 🇺🇸 United States

REUSABLE,NELLCOR OXISMART SPO2 EAR SENSOR

DI: 00840828190237 · Model: CSY001DN · CURBELL MEDICAL PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
REUSABLE,NELLCOR OXISMART SPO2 EAR SENSOR
Primary DI
00840828190237
Version / Model
CSY001DN
Catalog Number
28717
Company Name
CURBELL MEDICAL PRODUCTS, INC.
Labeler DUNS
796452311
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-11-07
Public Version
1
Public Version Date
2023-11-15
Public Version Status
New
Public Device Record Key
d06d06d2-5b88-4421-8ce1-ba8237baaeed

Device Description

REUSABLE,NELLCOR OXISMART SPO2 EAR SENSOR

Device Characteristics

Single Use
No
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
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
ILQ System, Communication, Powered

GMDN Terms

Code Name
47487 Electrical-only medical device connection cable, reusable

Identifiers

Type ID
Primary 00840828190237

Customer Contacts