Hsiner 10214

GUDID 04712688051286

NIPPV Silicone Face mask set

HSINER CO., LTD.

CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable

• Primary Device ID: 04712688051286
• NIH Device Record Key: 56a83201-3317-49ed-8ce9-89e8836b9c70
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hsiner
• Version Model Number: 1
• Catalog Number: 10214
• Company DUNS: 657310868
• Company Name: HSINER 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04712688051286 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102120

FDA Product Code

• CBK: Ventilator, Continuous, Facility Use

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-16
• Device Publish Date: 2020-09-08

On-Brand Devices [Hsiner]

• 04712688051460: COMFO CPAP Silicone Face mask set, size: S
• 14712688057445: HMEF REF70531
• 14712680057436: B/V Filter REF 70530
• 14712688052976: Pleated HME REF70544
• 04712688051286: NIPPV Silicone Face mask set
• 04711064681680: High flow nasal cannula, L
• 04711064681673: High flow nasal cannula, M
• 04711064681666: High flow nasal cannula, S
• 04711064681659: High Flow Nasal Cannula XS
• 04711064686791: Catheter Mount W/ collapsible tubing 18cm,22OD/15ID, 22ID
• 04711064686784: Corrugate Catheter Mount 18cm, 22OD/15ID; 22IDw/sampling port
• 04711064686777: Collapsible Catheter Mount, tubing length: 15cm, 22OD/15D,22ID, w/sampling port
• 04711064686760: Corrugate Catheter Mount, tubing length: 15cm, 22OD/15ID; 22ID
• 04711064686753: Corrugate Catheter Mount tubing length: 15cm, 22OD/15ID; 22ID