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 ID04712688051286
NIH Device Record Key56a83201-3317-49ed-8ce9-89e8836b9c70
Commercial Distribution StatusIn Commercial Distribution
Brand NameHsiner
Version Model Number1
Catalog Number10214
Company DUNS657310868
Company NameHSINER CO., LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104712688051286 [Primary]
GS104712688051286 [Primary]
GS104712688051286 [Primary]
GS104712688051286 [Primary]
GS104712688051286 [Primary]
GS104712688051286 [Primary]
GS104712688051286 [Primary]
GS104712688051286 [Primary]
GS104712688051286 [Primary]
GS104712688051286 [Primary]
GS104712688051286 [Primary]
GS104712688051286 [Primary]
GS104712688051286 [Primary]
GS104712688051286 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CBKVentilator, Continuous, Facility Use
CBKVentilator, Continuous, Facility Use
CBKVentilator, Continuous, Facility Use
CBKVentilator, Continuous, Facility Use
CBKVentilator, Continuous, Facility Use
CBKVentilator, Continuous, Facility Use
CBKVentilator, Continuous, Facility Use
CBKVentilator, Continuous, Facility Use
CBKVentilator, Continuous, Facility Use
CBKVentilator, Continuous, Facility Use
CBKVentilator, Continuous, Facility Use
CBKVentilator, Continuous, Facility Use
CBKVentilator, Continuous, Facility Use
CBKVentilator, Continuous, Facility Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-16
Device Publish Date2020-09-08

On-Brand Devices [Hsiner]

04712688051460COMFO CPAP Silicone Face mask set, size: S
14712688057445HMEF REF70531
14712680057436B/V Filter REF 70530
14712688052976Pleated HME REF70544
04712688051286NIPPV Silicone Face mask set

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