FDA.reportPublic FDA data

N/A

Primary DI
00607411945717
Brand
N/A
Company
SALTER LABS
Model
UTO271A
Catalog number
UTO271A
Device description
Utopia NE Full Face Mask - SM (with Black Headgear), pack of 5
Published
2017-09-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CBKVentilator, Continuous, Facility Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBKVentilator, Continuous, Facility UseAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K062019000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062019000RESPCARE HYBRID NE FACE MASK, MODEL TBD,; DISPOSABLE, MODEL TBDInnomed Technologies, Inc./Respcare, Inc.2006-08-17CBK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10607411945714PackageGS115In Commercial Distribution
00607411945717PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060741194571410607411945714
00607411945717006074119457176074119457170607411945717

GMDN Terms#

Term, Definition table
TermDefinition
CPAP/BPAP face mask, single-useA non-sterile, flexible, form-shaped device designed to be placed over a user's nose and 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/silicone materials that create an airtight seal around the nose and mouth. It is available in various designs and sizes and stabilized with a headstrap. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

Contacts#

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

Regulatory Flags#

DUNS number
022721133
Device count
1
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00607411919008Salter Labs® Adult Comfort Face Tent131032026-06-09
00607411919053Salter Labs® Oxygen Mask131242026-06-09
00607411919060Salter Labs® Oxygen Mask131252026-06-09
00607411919084MedTronic Cannula133012026-06-09
00607411919107Salter Labs® Nasal Cannula133072026-06-09
00607411919138Salter Labs® Nasal Cannula133102026-06-09
00607411919206MedTronic ETCo2 Cannula133402026-06-09
00607411919220Salter Labs® Oxygen Tubing134002026-06-09
00607411919237Salter Labs® Oxygen Tubing134042026-06-09
00607411919244Salter Labs® Oxygen Tubing134072026-06-09
00607411919251Salter Labs® Oxygen Tubing (MedTronic)134082026-06-09
00607411919299MedTronic NebuTech135002026-06-09
00607411919329Salter Labs® NebuTech®135062026-06-09
00607411919350Salter Labs® Full Kit Nebulizer139512026-06-09
00607411000737N/A8900-148900-142016-09-24
00607411006814N/ASO-1343SO-13432016-09-24
00607411009297N/ASO-1666-0SO-1666-02016-09-24
00607411102738N/A7914-147914-142016-12-22
00607411300059N/ASO-388-0SO-388-02016-09-24
00607411700002N/A7100-07100-02016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344102655MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
10197344102662MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
10197344102679MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
10197344102686MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
10197344102693MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
10197344102709MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
09420012477477F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012477484F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012477491F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012480446F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012480460F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012480484F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
08056814676223DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676247DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676254DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676261DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676377DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676384DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676391DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676407DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676360DIMARHMC PREMEDICAL SPACBK2025-03-20
10889483603987AirLife™AIRLIFECBK2025-02-26
10889483603994AirLife™AIRLIFECBK2025-02-26
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10889483604090AirLife™AIRLIFECBK2025-02-26