FDA UDI In Commercial Distribution 🇺🇸 United States

DISP NONN COMP SPO2 SNSR,6000CI,INFT,20"

DI: 00840828190459 · Model: CSA020DI-M100 · CURBELL MEDICAL PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
DISP NONN COMP SPO2 SNSR,6000CI,INFT,20"
Primary DI
00840828190459
Version / Model
CSA020DI-M100
Catalog Number
28791
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
db0f31f6-be71-49f0-972c-32e4ff787fed

Device Description

DISP NONIN COMP SPO2 SNSR,6000CI,INFANT,20”,NONWVN FABRIC,NON-STRL,EA

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
No
MRI Safety
MR Unsafe
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
DSA Cable, Transducer And Electrode, Patient, (Including Connector)

GMDN Terms

Code Name
31658 Pulse oximeter probe, single-use

Identifiers

Type ID
Package 10840828190456
Primary 00840828190459

Customer Contacts

Premarket Submissions

Submission Number Supplement Number
K182220 000