KYOLING

GUDID 16946594904199

HangZhou Jinlin Medical Appliances Co.,Ltd.

Cardiopulmonary resuscitation mask, reusable Cardiopulmonary resuscitation mask, reusable

• Primary Device ID: 16946594904199
• NIH Device Record Key: c909432f-7541-469c-9213-fa7cc1c4c7cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KYOLING
• Version Model Number: HX0. 12
• Company DUNS: 529988628
• Company Name: HangZhou Jinlin Medical Appliances 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: true
• Serial Number: false
• Manufacturing Date: true
• 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
GS1	16946594904199 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142764

FDA Product Code

• CBP: Valve, Non-Rebreathing

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-03-21