NaviCam Small Bowel Capsule Endoscopy System CP-US-7005, CP-US-7006

GUDID 16921010800491

The Capsule is a capsule endoscope capable of capturing images inside the human digestive tract.

ANKON Technologies Co.,Ltd.

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• Primary Device ID: 16921010800491
• NIH Device Record Key: f086d5f3-b0c7-4d37-838b-c5448c1982c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NaviCam Small Bowel Capsule Endoscopy System
• Version Model Number: Capsule/AKES-11SW
• Catalog Number: CP-US-7005, CP-US-7006
• Company DUNS: 549329633
• Company Name: ANKON Technologies Co.,Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• 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	06921010800494 [Primary]
GS1	16921010800491 [Package]; Contains: 06921010800494; Package: box [10 Units]; In Commercial Distribution

FDA Product Code

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

Sterilization

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

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