NaviCam Small Bowel Capsule Endoscopy System MC-US-1006

GUDID 06921010800517

The AKR-1 Data Recorder is a portable data receiving unit with built-in rechargeable lithium battery placed inside the examination cloth worn by the patient during examination. It is used for receiving image data wirelessly transmitted from the Capsule.

ANKON Technologies Co.,Ltd.

Video capsule endoscopy monitoring kit

• Primary Device ID: 06921010800517
• NIH Device Record Key: 192865f0-a4a0-48d6-9e30-d6000dacad95
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NaviCam Small Bowel Capsule Endoscopy System
• Version Model Number: Recorder/AKR-1
• Catalog Number: MC-US-1006
• Company DUNS: 549329633
• Company Name: ANKON Technologies 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: 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

Customer Support Contacts

• Phone: +8613397176599
• Email: sifeng.wang@ankoninc.com.cn
• Phone: +8613397176599
• Email: sifeng.wang@ankoninc.com.cn
• Phone: +8613397176599
• Email: sifeng.wang@ankoninc.com.cn
• Phone: +8613397176599
• Email: sifeng.wang@ankoninc.com.cn
• Phone: +8613397176599
• Email: sifeng.wang@ankoninc.com.cn
• Phone: +8613397176599
• Email: sifeng.wang@ankoninc.com.cn
• Phone: +8613397176599
• Email: sifeng.wang@ankoninc.com.cn
• Phone: +8613397176599
• Email: sifeng.wang@ankoninc.com.cn
• Phone: +8613397176599
• Email: sifeng.wang@ankoninc.com.cn
• Phone: +8613397176599
• Email: sifeng.wang@ankoninc.com.cn
• Phone: +8613397176599
• Email: sifeng.wang@ankoninc.com.cn
• Phone: +8613397176599
• Email: sifeng.wang@ankoninc.com.cn
• Phone: +8613397176599
• Email: sifeng.wang@ankoninc.com.cn
• Phone: +8613397176599
• Email: sifeng.wang@ankoninc.com.cn
• Phone: +8613397176599
• Email: sifeng.wang@ankoninc.com.cn
• Phone: +8613397176599
• Email: sifeng.wang@ankoninc.com.cn
• Phone: +8613397176599
• Email: sifeng.wang@ankoninc.com.cn

Device Identifiers

Device Issuing Agency	Device ID
GS1	06921010800517 [Primary]

FDA Product Code

• NEZ: System, Imaging, Gastrointestinal, Wireless, Capsule

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-01-01
• Device Publish Date: 2022-12-27

On-Brand Devices [ NaviCam Small Bowel Capsule Endoscopy System]

• 06921010800531: The Locator is a portable magnetic scanning device with built-in rechargeable lithium battery. I
• 06921010800524: It is used for receiving image data wirelessly transmitted from the Capsule.
• 06921010800517: The AKR-1 Data Recorder is a portable data receiving unit with built-in rechargeable lithium bat
• 16921010800507: The Capsule is a capsule endoscope capable of capturing images inside the human digestive tract
• 16921010800491: The Capsule is a capsule endoscope capable of capturing images inside the human digestive tract