Smart Cable NMT Module and Accessories DH-101P

GUDID 04931921000045

Holder

NIHON KOHDEN CORPORATION

General-purpose multi-parameter bedside monitor

• Primary Device ID: 04931921000045
• NIH Device Record Key: 33bda348-39b8-4c79-9c35-593809dd13f7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Smart Cable NMT Module and Accessories
• Version Model Number: DH-101P
• Catalog Number: DH-101P
• Company DUNS: 690568050
• Company Name: NIHON KOHDEN CORPORATION
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04931921000045 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201949

FDA Product Code

• KOI: Stimulator, Nerve, Peripheral, Electric

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: 2021-10-05
• Device Publish Date: 2021-09-27

On-Brand Devices [Smart Cable NMT Module and Accessories]

• 04931921011089: Main cable
• 04931921006719: Disposable electrodes
• 04931921000045: Holder