NaviCam Small Bowel Capsule Endoscopy System SB-US-2006

GUDID 06921010800531

The Locator is a portable magnetic scanning device with built-in rechargeable lithium battery. It is used to turn the capsule on before it is swallowed by the patient and can be used for detecting whether a capsule is inside the human body and probing its approximate position.

ANKON Technologies Co.,Ltd.

Video capsule endoscopy monitoring kit

• Primary Device ID: 06921010800531
• NIH Device Record Key: d1ae7db8-98c8-4608-82a4-d26054c8405b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NaviCam Small Bowel Capsule Endoscopy System
• Version Model Number: Locator/AKS-1
• Catalog Number: SB-US-2006
• 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	06921010800531 [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