FDA.reportPublic FDA data

N/A

Primary DI
10607411942454
Brand
N/A
Company
SALTER LABS
Model
HYB525
Catalog number
HYB525
Device description
Hybrid Pillows - LG
Published
2017-09-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K052227000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K052227000RESPCARE FACE MASKRespcare, Inc.2005-10-28BZD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10607411942454PackageGS196In Commercial Distribution
00607411942457PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060741194245410607411942454
00607411942457006074119424576074119424570607411942457

GMDN Terms#

Term, Definition table
TermDefinition
CPAP/BPAP oral maskA flexible, form-shaped device designed to be fitted to the user's mouth to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV). It is typically made of plastic and/or silicone materials that create an airtight seal around the patient's mouth; this providing a solution for mouth breathers and patients with chronic nasal obstruction. It is available in various designs and sizes and stabilized with a headstrap. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)421-0024customercare@salterlabs.com

Regulatory Flags#

DUNS number
022721133
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00607411888922N/AM5120-0M5120-02016-09-24
00607411917615n/aOTC-203-25 (QTY1)OTC-203-25 (QTY1)2016-11-30
00607411917646n/aOTC-203-50 (QTY1)OTC-203-50 (QTY1)2016-11-30
00607411918346Salter AIRE EliteSO-1774BESO-1774BE2016-09-24
00607411400711N/ASO-431SO-4312016-09-24
10607411920117N/AM123138-0M123138-02016-09-24
00607411000409N/ASO-1394SO-13942016-09-24
00607411000461N/ASO-1392-0SO-1392-02016-09-24
00607411000478N/ASO-1393SO-13932016-09-24
00607411005756N/ASO-1608-0SO-1608-02016-09-24
00607411006067N/ASO-1613-0SO-1613-02016-09-24
00607411006319N/ASO-1635-0SO-1635-02016-09-24
00607411006593N/AE7600-0E7600-02018-03-12
00607411006715N/ASO-1658-0SO-1658-02016-09-24
00607411006722N/ASO-1352SO-13522016-09-24
00607411006814N/ASO-1343SO-13432016-09-24
00607411007408N/ASO-1738-0SO-1738-02016-09-24
00607411007576N/ASO-500-0SO-500-02016-09-24
00607411007644N/ASO-1756-0SO-1756-02016-09-24
00607411007781N/ASO-1767-0SO-1767-02016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848530106461CPAP MaskSunset Healthcare Solutions, Inc.BZD2025-07-22
00848530106478CPAP MaskSunset Healthcare Solutions, Inc.BZD2025-07-22
00848530106485CPAP Mask CushionSunset Healthcare Solutions, Inc.BZD2025-07-22
00848530106492CPAP Mask CushionSunset Healthcare Solutions, Inc.BZD2025-07-22
00848530106508CPAP Mask CushionSunset Healthcare Solutions, Inc.BZD2025-07-22
00848530106515CPAP MaskSunset Healthcare Solutions, Inc.BZD2025-07-17
00848530106355CPAP MaskSunset Healthcare Solutions, Inc.BZD2025-06-18
00848530106362Nasal CPAP MaskSunset Healthcare Solutions, Inc.BZD2025-06-18
00848530106379CPAP MaskSunset Healthcare Solutions, Inc.BZD2025-06-18
00848530106386CPAP MaskSunset Healthcare Solutions, Inc.BZD2025-06-18
00848530106393CPAP MaskSunset Healthcare Solutions, Inc.BZD2025-06-18
00848530106409Nasal CPAP MaskSunset Healthcare Solutions, Inc.BZD2025-06-18
10889483586358Vital Signs™AIRLIFEBZD2025-02-18
00848530081638CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530085230CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530090661CPAP MaskSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530090678CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530090685CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530090692CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530090708CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530090715CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530090722CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530090739CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530090746CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530097103CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530097110CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530097127CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530097134CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530097141CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530097158CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29