FUKUDA DENSHI

GUDID 04538612904585

FUKUDA DENSHI CO.,LTD.

Electrocardiographic recording paper

• Primary Device ID: 04538612904585
• NIH Device Record Key: 2df46e7d-be07-4868-8c8e-c318be0a7411
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FUKUDA DENSHI
• Version Model Number: OP-621TE
• Company DUNS: 690671011
• Company Name: FUKUDA DENSHI CO.,LTD.
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04538612904585 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K981066

FDA Product Code

• DSF: Recorder, Paper Chart

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-29
• Device Publish Date: 2022-11-21

On-Brand Devices [FUKUDA DENSHI]

• 04538612914102: CIO-09CTP-5NA
• 04538612914096: CIO-09CTP-4NA
• 04538612914089: CIO-09CTP-3NA
• 04538612914072: CIT-03CRH-A
• 04538612914065: CIT-02CRH-A
• 04538612914058: CIT-01CRH-A
• 04538612913693: LC-8018TC
• 04538612913686: LC-8016TC
• 04538612913679: DSC-8410
• 04538612913549: DS-8007M
• 04538612913532: DS-8007N
• 04538612913440: CMF-702-5FA
• 04538612913433: CMF-700-5CFA
• 04538612912634: LC-8210
• 04538612912603: DSC-8530
• 04538612912597: DSC-8510
• 04538612912498: CUF-143LH
• 04538612912481: CUF-143SH
• 04538612912474: CUF-143MH
• 04538612912467: CUF-142LH
• 04538612912450: CUF-142SH
• 04538612912443: CUF-142MH
• 04538612912320: ASV-05U
• 04538612912306: ASV-04U
• 04538612912283: VS-2000
• 04538612912047: DS-8900
• 04538612911477: CUF-8506
• 04538612911460: CUF-8505
• 04538612911453: CUF-8504
• 04538612911446: CUF-8503
• 04538612911439: CUF-8502
• 04538612911422: CUF-8501
• 04538612911392: CUF-7105
• 04538612911385: CUF-7104
• 04538612911378: CUF-7103
• 04538612911361: CUF-7102A
• 04538612911354: CUF-7101
• 04538612911194: CMO-07FT-5NAB
• 04538612911187: CMO-07FT-4NAB
• 04538612911170: CMO-07FT-3NAB
• 04538612911064: LX-7230N(G)
• 04538612911057: LX-7120(G)
• 04538612910623: CPR-02AKPDA2033
• 04538612910609: CPV-02AKPA-2036
• 04538612910586: CP-202L-2037
• 04538612910531: CP-105L-2038
• 04538612910326: DS-8100M
• 04538612910302: DS-8100N
• 04538612910289: UF-760AG
• 04538612910272: CMO-07FTP-10NAB