6051-0000-216

GUDID B404605100002160

CITY TECHNOLOGY LIMITED

Respiratory oxygen sensor

• Primary Device ID: B404605100002160
• NIH Device Record Key: a02b2c11-1374-4bae-a372-e40717f5ae56
• Commercial Distribution Discontinuation: 2019-02-21
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: 6051-0000-216
• Version Model Number: 6051-0000-216
• Company DUNS: 227246220
• Company Name: CITY TECHNOLOGY LIMITED
• 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: false
• Expiration Date: true
• 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
HIBCC	B404605100002160 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041773

FDA Product Code

• CCL: Analyzer, Gas, Oxygen, Gaseous-Phase

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-22
• Device Publish Date: 2016-09-20

Devices Manufactured by CITY TECHNOLOGY LIMITED

• B404605100002160 - 6051-0000-216: 2019-02-22
• B404605100002160 - 6051-0000-216: 2019-02-22
• B404605100002170 - 6051-0000-217: 2019-02-22
• B404605100002180 - 6051-0000-218: 2019-02-22
• B404605100002190 - 6051-0000-219: 2019-02-22
• B404605100002200 - 6051-0000-220: 2019-02-22
• B404605100002220 - 6051-0000-222: 2019-02-22
• B404605000041100 - 6050-0004-110: 2018-07-06
• B404660012786000 - 6600-1278-600: 2018-07-06 Medical Oxygen Sensor, SERV02 GP