Celsius D8BTCBL252RT

GUDID 10846835006421

BIOSENSE WEBSTER INC.

Cardiac radio-frequency ablation system catheter

Primary Device ID	10846835006421
NIH Device Record Key	eedca3ff-74b3-437f-b5a6-0151bd8da0f6
Commercial Distribution Status	In Commercial Distribution
Brand Name	Celsius
Version Model Number	D8BTCBL252RT
Catalog Number	D8BTCBL252RT
Company DUNS	020163218
Company Name	BIOSENSE WEBSTER INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(800)729-9010
Email	RA-BWIUS-Complaints@its.jnj.com
Phone	+1(800)729-9010
Email	RA-BWIUS-Complaints@its.jnj.com
Phone	+1(800)729-9010
Email	RA-BWIUS-Complaints@its.jnj.com
Phone	+1(800)729-9010
Email	RA-BWIUS-Complaints@its.jnj.com
Phone	+1(800)729-9010
Email	RA-BWIUS-Complaints@its.jnj.com
Phone	+1(800)729-9010
Email	RA-BWIUS-Complaints@its.jnj.com
Phone	+1(800)729-9010
Email	RA-BWIUS-Complaints@its.jnj.com
Phone	+1(800)729-9010
Email	RA-BWIUS-Complaints@its.jnj.com
Phone	+1(800)729-9010
Email	RA-BWIUS-Complaints@its.jnj.com
Phone	+1(800)729-9010
Email	RA-BWIUS-Complaints@its.jnj.com
Phone	+1(800)729-9010
Email	RA-BWIUS-Complaints@its.jnj.com
Phone	+1(800)729-9010
Email	RA-BWIUS-Complaints@its.jnj.com
Phone	+1(800)729-9010
Email	RA-BWIUS-Complaints@its.jnj.com
Phone	+1(800)729-9010
Email	RA-BWIUS-Complaints@its.jnj.com
Phone	+1(800)729-9010
Email	RA-BWIUS-Complaints@its.jnj.com
Phone	+1(800)729-9010
Email	RA-BWIUS-Complaints@its.jnj.com
Phone	+1(800)729-9010
Email	RA-BWIUS-Complaints@its.jnj.com
Phone	+1(800)729-9010
Email	RA-BWIUS-Complaints@its.jnj.com
Phone	+1(800)729-9010
Email	RA-BWIUS-Complaints@its.jnj.com
Phone	+1(800)729-9010
Email	RA-BWIUS-Complaints@its.jnj.com
Phone	+1(800)729-9010
Email	RA-BWIUS-Complaints@its.jnj.com
Phone	+1(800)729-9010
Email	RA-BWIUS-Complaints@its.jnj.com
Phone	+1(800)729-9010
Email	RA-BWIUS-Complaints@its.jnj.com
Phone	+1(800)729-9010
Email	RA-BWIUS-Complaints@its.jnj.com
Phone	+1(800)729-9010
Email	RA-BWIUS-Complaints@its.jnj.com
Phone	+1(800)729-9010
Email	RA-BWIUS-Complaints@its.jnj.com
Phone	+1(800)729-9010
Email	RA-BWIUS-Complaints@its.jnj.com
Phone	+1(800)729-9010
Email	RA-BWIUS-Complaints@its.jnj.com
Phone	+1(800)729-9010
Email	RA-BWIUS-Complaints@its.jnj.com
Phone	+1(800)729-9010
Email	RA-BWIUS-Complaints@its.jnj.com
Phone	+1(800)729-9010
Email	RA-BWIUS-Complaints@its.jnj.com
Phone	+1(800)729-9010
Email	RA-BWIUS-Complaints@its.jnj.com
Phone	+1(800)729-9010
Email	RA-BWIUS-Complaints@its.jnj.com
Phone	+1(800)729-9010
Email	RA-BWIUS-Complaints@its.jnj.com
Phone	+1(800)729-9010
Email	RA-BWIUS-Complaints@its.jnj.com
Phone	+1(800)729-9010
Email	RA-BWIUS-Complaints@its.jnj.com
Phone	+1(800)729-9010
Email	RA-BWIUS-Complaints@its.jnj.com

Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is damaged
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is opened
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry \| Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is damaged
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is opened
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry \| Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is damaged
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is opened
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry \| Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is damaged
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is opened
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry \| Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is damaged
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is opened
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry \| Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is damaged
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is opened
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry \| Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is damaged
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is opened
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry \| Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is damaged
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is opened
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry \| Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is damaged
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is opened
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry \| Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is damaged
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is opened
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry \| Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is damaged
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is opened
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry \| Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is damaged
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is opened
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry \| Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is damaged
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is opened
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry \| Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is damaged
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is opened
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry \| Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is damaged
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is opened
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry \| Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is damaged
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is opened
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry \| Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is damaged
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is opened
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry \| Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is damaged
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is opened
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry \| Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is damaged
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is opened
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry \| Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is damaged
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is opened
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry \| Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is damaged
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is opened
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry \| Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is damaged
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is opened
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry \| Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is damaged
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is opened
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry \| Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is damaged
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is opened
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry \| Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is damaged
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is opened
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry \| Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is damaged
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is opened
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry \| Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is damaged
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is opened
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry \| Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is damaged
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is opened
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry \| Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is damaged
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is opened
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry \| Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is damaged
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is opened
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry \| Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is damaged
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is opened
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry \| Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is damaged
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is opened
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is damaged
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is opened
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is damaged
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is opened
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is damaged
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is opened
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is damaged
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is opened
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is damaged
Special Storage Condition, Specify	Between 0 and 0 *Do not use if package is opened
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	10846835006421 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Approval: P950005

FDA Product Code

DRF	CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2021-06-28
Device Publish Date	2014-11-05

On-Brand Devices [Celsius]

10846835000405	D7TCFL252RT
10846835006681	D8BTGL
10846835006674	D8BTG5L
10846835006667	D8BTFL252RT
10846835006643	D8BTF5L252RT
10846835006636	D8BTEL252RT
10846835006612	D8BTDL252RT
10846835006605	D8BTDG252RT
10846835006599	D8BTD5L252RT
10846835006575	D8BTCL252RT
10846835006551	D8BTCJ5L
10846835006520	D8BTCGL
10846835006513	D8BTCG5L
10846835006506	D8BTCFL252RT
10846835006483	D8BTCF5L252RT
10846835006476	D8BTCEL252RT
10846835006469	D8BTCE5L252RT
10846835006452	D8BTCDG252RT
10846835005370	D7BTDL252RT
10846835005356	D7BTD5L252RT
10846835005301	D7BTCJ5L
10846835005257	D7BTCFL252RT
10846835005233	D7BTCEL252RT
10846835005219	D7BTCDL252RT
10846835005172	D7BTCBL252RT
10846835004731	D6TFL252RT
10846835004724	D6TEL252RT
10846835004717	D6TDL252RT
10846835004694	D6TCEL252RT
10846835004670	D6TCDL252RT
10846835004663	D6TCDG252RT
10846835004649	D6TCBL252RT
10846835004632	D6TCBG252RT
10846835004625	D6TCAL252RT
10846835004618	D6TCAG252RT
10846835004601	D6TBL252RT
10846835001662	112547S
10846835000436	D8BTCDL252RT
10846835000429	D7TFL252RT
10846835000412	D7TDL252RT
10846835000382	D7TCDL252RT
10846835000375	D7TCCL252RT
10846835000368	D7TCBL252RT
10846835006421	D8BTCBL252RT
10846835006414	D8BTCBG252RT
10846835006384	D8BTBL252RT
10846835006247	D7TEL252RT
10846835006216	D7TCPSL252RT
10846835006209	D7TCL252RT
10846835006179	D7TCFG252RT

Trademark Results [Celsius]

Mark Image Registration \| Serial	Company Trademark Application Date
CELSIUS 98641708 not registered Live/Pending	LCB Battery, LLC 2024-07-10
CELSIUS 97310915 not registered Live/Pending	Sartorius Stedim North America Inc. 2022-03-14
CELSIUS 97152681 not registered Live/Pending	DuraRoof, LLC 2021-12-02
CELSIUS 97104016 not registered Live/Pending	CartScale LLC 2021-11-02
CELSIUS 97076032 not registered Live/Pending	CartScale LLC 2021-10-15
CELSIUS 97076030 not registered Live/Pending	CartScale LLC 2021-10-15
CELSIUS 90301127 not registered Live/Pending	Celsius Products Holdings, Inc. 2020-11-05
CELSIUS 88038637 not registered Live/Pending	Celsius Network Inc 2018-07-16
CELSIUS 88038626 5690307 Live/Registered	Celsius Network Inc 2018-07-16
CELSIUS 87512979 not registered Dead/Abandoned	Mule-Hide Products Co., Inc. 2017-06-30
CELSIUS 87287118 not registered Live/Pending	Celsius Products Holdings, Inc. 2017-01-02
CELSIUS 86924652 not registered Dead/Abandoned	Celsius LLC 2016-03-01