GUDID 00802526610400

BATTERY

BOSTON SCIENTIFIC CORPORATION

Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack
Primary Device ID00802526610400
NIH Device Record Key19f09029-0537-471c-b8e1-9866cfa96e06
Commercial Distribution StatusIn Commercial Distribution
Version Model Number6753
Company DUNS106295384
Company NameBOSTON SCIENTIFIC CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100802526610400 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OSRPacemaker/icd/crt non-implanted components

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-13
Device Publish Date2020-05-05

Devices Manufactured by BOSTON SCIENTIFIC CORPORATION

08714729977414 - GreenLight XPS™2024-07-17 Laser System
08714729347897 - Electrophysiology Cable2024-07-11 Sterile Cable
08714729452805 - Chilli II®2024-07-11 Cooled Ablation Catheter
08714729452843 - Chilli II®2024-07-11 Cooled Ablation Catheter
08714729452850 - Chilli II®2024-07-11 Cooled Ablation Catheter
08714729454533 - Model 2104 Tubing Kit2024-07-11 Peristaltic Pump Delivery Extension Tube Set
08714729454816 - CircuCool™ 8005 Pump2024-07-11 Model 8005 Pump
08714729767152 - Electrophysiology Cable2024-07-11 Sterile Cable

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