FDA UDI In Commercial Distribution 🇺🇸 United States

DISP NLCR COMPAT SPO2 SNSR,OXMX,MAXN

DI: 00840828180641 · Model: CSA001DN-P200 · CURBELL MEDICAL PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1

Basic Information

Brand Name
DISP NLCR COMPAT SPO2 SNSR,OXMX,MAXN
Primary DI
00840828180641
Version / Model
CSA001DN-P200
Catalog Number
26248
Company Name
CURBELL MEDICAL PRODUCTS, INC.
Labeler DUNS
796452311
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-08-07
Public Version
3
Public Version Date
2023-07-31
Public Version Status
Update
Public Device Record Key
ca7199f6-69e8-4674-ab5a-daa9bec32d3e

Device Description

DISP NLCR COMPAT SPO2 SNSR,OXMX,MAXN

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
Primary 00840828180641
Package 10840828180648
Package 00840828189491

Customer Contacts

Premarket Submissions

Submission Number Supplement Number
K182220 000