FDA.reportPublic FDA data

Hsiner

Primary DI
04712688051460
Brand
Hsiner
Company
HSINER CO., LTD.
Model
1
Catalog number
10243
Device description
COMFO CPAP Silicone Face mask set, size: S
Published
2017-06-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
BZDVentilator, Non-Continuous (Respirator)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZDVentilator, Non-Continuous (Respirator)Anesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04712688051460PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04712688051460047126880514604712688051460

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
657310868
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04712688050661Hsiner1202512026-05-21
04712688050678Hsiner1202522026-05-21
04712688050685Hsiner1202532026-05-21
04712688050692Hsiner1202542026-05-21
04712688050708Hsiner1202552026-05-21
04712688051453Hsiner1102952026-05-21
04712688052115Hsiner1201202026-05-21
04712688053822Hsiner1303002026-05-21
04712688051286Hsiner1102142020-09-08
04711064686753Hsiner1VY70136-22F2022-08-22
04711064686760Hsiner1VY70134-22F2022-08-22
04711064686777Hsiner1VY70133-22F2022-08-22
04711064686784Hsiner1VY701392022-08-22
04711064686791Hsiner1VY70132-000-22F2022-08-22
04711064681659Hsiner1149322021-07-02
04711064681666Hsiner1149332021-07-02
04711064681673Hsiner1149342021-07-02
04711064681680Hsiner1149352021-07-02
04712688057448Hsiner1705312020-07-13
04712688051439Hsiner1102852020-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848530110147Oxygen KitSunset Healthcare Solutions, Inc.BZD2026-11-04
00848530110192CPAP MaskSunset Healthcare Solutions, Inc.BZD2026-11-04
00848530110208CPAP MaskSunset Healthcare Solutions, Inc.BZD2026-11-04
00848530110215CPAP MaskSunset Healthcare Solutions, Inc.BZD2026-11-04
00848530110222CPAP MaskSunset Healthcare Solutions, Inc.BZD2026-11-04
00848530110130Nasal CPAP MaskSunset Healthcare Solutions, Inc.BZD2026-11-03
00814747025017Arie Full Face Vented Mask KitSLEEPNET, CORP.BZD2026-10-23
00814747025024Arie Full Face Vented Mask, SmallSLEEPNET, CORP.BZD2026-10-23
00814747025031Arie Full Face Vented Mask, MediumSLEEPNET, CORP.BZD2026-10-23
00814747025048Arie Full Face Vented Mask, LargeSLEEPNET, CORP.BZD2026-10-23
00814747025055Ascend Full Face Vented Mask KitSLEEPNET, CORP.BZD2026-10-23
00814747025062Ascend Full Face Vented Mask, SmallSLEEPNET, CORP.BZD2026-10-23
00814747025079Ascend Full Face Vented Mask, MediumSLEEPNET, CORP.BZD2026-10-23
00814747025086Ascend Full Face Vented Mask, LargeSLEEPNET, CORP.BZD2026-10-23
00814747025093Arie Nasal Vented Mask KitSLEEPNET, CORP.BZD2026-10-23
00814747025109Arie Nasal Vented Mask, SmallSLEEPNET, CORP.BZD2026-10-23
00814747025116Arie Nasal Vented Mask, MediumSLEEPNET, CORP.BZD2026-10-23
00814747025123Arie Nasal Vented Mask, LargeSLEEPNET, CORP.BZD2026-10-23
00814747025130Ascend Nasal Vented Mask KitSLEEPNET, CORP.BZD2026-10-23
00814747025147Ascend Nasal Vented Mask, SmallSLEEPNET, CORP.BZD2026-10-23
00814747025154Ascend Nasal Vented Mask, SmallSLEEPNET, CORP.BZD2026-10-23
00814747025161Ascend Nasal Vented Mask, LargeSLEEPNET, CORP.BZD2026-10-23
00814747025178IQ 2 Nasal MaskSLEEPNET, CORP.BZD2026-10-23
00814747025185Phantom 2 Nasal Vented MaskSLEEPNET, CORP.BZD2026-10-23
00814747025192MiniMe 2 Pediatric Nasal Vented Mask, Extra SmallSLEEPNET, CORP.BZD2026-10-23
00814747025208MiniMe 2 Pediatric Nasal Vented Mask, SmallSLEEPNET, CORP.BZD2026-10-23
00814747025215MiniMe 2 Pediatric Nasal Vented Mask, MediumSLEEPNET, CORP.BZD2026-10-23
00814747025222MiniMe 2 Pediatric Nasal Vented Mask, LargeSLEEPNET, CORP.BZD2026-10-23
00814747025314Novaplus Full Face Vented Mask, Extra LargeSLEEPNET, CORP.BZD2026-10-23
00814747025321Novaplus Full Face Vented Mask, LargeSLEEPNET, CORP.BZD2026-10-23