DISP NK COMP SPO2 SNSR,TL-272T,PDTRC,39",CLR FLM,NON-STRL,EACH 28175

GUDID 10840828186008

DISP NK COMP SPO2 SNSR,TL-272T,PDTRC,39",CLR FLM,NON-STRL,EACH

CURBELL MEDICAL PRODUCTS, INC.

Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use
Primary Device ID10840828186008
NIH Device Record Key1b2dfc27-05de-431e-9ea3-a0e9c943fe84
Commercial Distribution StatusIn Commercial Distribution
Brand NameDISP NK COMP SPO2 SNSR,TL-272T,PDTRC,39",CLR FLM,NON-STRL,EACH
Version Model NumberCSA027DP-P100
Catalog Number28175
Company DUNS796452311
Company NameCURBELL MEDICAL PRODUCTS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-235-7500
Emailmwinter@curbellmedical.com
Phone1-800-235-7500
Emailmwinter@curbellmedical.com
Phone1-800-235-7500
Emailmwinter@curbellmedical.com
Phone1-800-235-7500
Emailmwinter@curbellmedical.com
Phone1-800-235-7500
Emailmwinter@curbellmedical.com
Phone1-800-235-7500
Emailmwinter@curbellmedical.com
Phone1-800-235-7500
Emailmwinter@curbellmedical.com
Phone1-800-235-7500
Emailmwinter@curbellmedical.com
Phone1-800-235-7500
Emailmwinter@curbellmedical.com
Phone1-800-235-7500
Emailmwinter@curbellmedical.com
Phone1-800-235-7500
Emailmwinter@curbellmedical.com
Phone1-800-235-7500
Emailmwinter@curbellmedical.com
Phone1-800-235-7500
Emailmwinter@curbellmedical.com
Phone1-800-235-7500
Emailmwinter@curbellmedical.com
Phone1-800-235-7500
Emailmwinter@curbellmedical.com
Phone1-800-235-7500
Emailmwinter@curbellmedical.com
Phone1-800-235-7500
Emailmwinter@curbellmedical.com
Phone1-800-235-7500
Emailmwinter@curbellmedical.com
Phone1-800-235-7500
Emailmwinter@curbellmedical.com
Phone1-800-235-7500
Emailmwinter@curbellmedical.com
Phone1-800-235-7500
Emailmwinter@curbellmedical.com
Phone1-800-235-7500
Emailmwinter@curbellmedical.com
Phone1-800-235-7500
Emailmwinter@curbellmedical.com
Phone1-800-235-7500
Emailmwinter@curbellmedical.com
Phone1-800-235-7500
Emailmwinter@curbellmedical.com
Phone1-800-235-7500
Emailmwinter@curbellmedical.com
Phone1-800-235-7500
Emailmwinter@curbellmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100840828186001 [Primary]
GS100840828189583 [Package]
Contains: 00840828186001
Package: Case [24 Units]
In Commercial Distribution
GS110840828186008 [Package]
Contains: 00840828186001
Package: Case [30 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQAOximeter
DSACable, Transducer And Electrode, Patient, (Including Connector)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-07
Device Publish Date2023-07-28

Devices Manufactured by CURBELL MEDICAL PRODUCTS, INC.

00840828182294 - REUS,NCLR OXSMRT SPO2 SNSR,9.5',LG CLAM2024-04-18 REUS,NCLR OXSMRT SPO2 SNSR,9.5',LG CLAM
00840828182300 - REUS,NLCR OXSMRT SPO2 SNSR,3.3',LG CLAM2024-04-18 REUS,NLCR OXSMRT SPO2 SNSR,3.3',LG CLAM
00840828182317 - REUS,NLCR OXSMRT SPO2 SNSR,3.3',LG SOFT2024-04-18 REUS,NLCR OXSMRT SPO2 SNSR,3.3',LG SOFT
00840828182324 - REUS,NLCR OXSMRT SPO2 SNSR,3.3',SM SOFT2024-04-18 REUS,NLCR OXSMRT SPO2 SNSR,3.3',SM SOFT
00840828182331 - REUS,NLCR OXMAX SPO2 SNSR,9.5',LG CLAM2024-04-18 REUS,NLCR OXMAX SPO2 SNSR,9.5',LG CLAM
00840828182348 - REUS,NLCR OXMAX SPO2 SNSR,3.3',LG CLAM2024-04-18 REUS,NLCR OXMAX SPO2 SNSR,3.3',LG CLAM
00840828182355 - REUS,NLCR OXMAX SPO2 SNSR,9.5',LG SOFT2024-04-18 REUS,NLCR OXMAX SPO2 SNSR,9.5',LG SOFT
00840828182362 - REUS,NLCR OXMAX SPO2 SNSR,3.3',LG SOFT2024-04-18 REUS,NLCR OXMAX SPO2 SNSR,3.3',LG SOFT

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.