FDA.reportPublic FDA data

N/A

Primary DI
00607411800788
Brand
N/A
Company
SALTER LABS
Model
1140-7
Catalog number
1140-7
Device description
Pediatric Oxygen Mask High Concentration Non-rebreather, 7’ (2.1 m) supply tube, elastic strap fixation.
Published
2016-11-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BYGMASK, OXYGEN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYGMask, OxygenAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10607411800785PackageGS150In Commercial Distribution
00607411800788PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060741180078510607411800785
00607411800788006074118007886074118007880607411800788

GMDN Terms#

Term, Definition table
TermDefinition
Non-rebreathing oxygen face maskA non-sterile, flexible, form-shaped device designed to be placed over the nose and mouth to deliver air of high oxygen (O2) concentration to a patient's airway. It typically includes two unidirectional valves, one that closes during inspiration to prevent room air mixing with oxygen in a reservoir bag, and one that closes during exhalation to prevent exhaled respiratory gases from entering the reservoir bag. It is made of soft, flexible polymers designed to create an airtight seal against the patient's face. It may include tubing, and various valves and connectors, however other respiratory equipment (e.g., nebulizer, humidifier, CPAP device) is not included. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius
Special Storage Condition, Specify00N/A
Storage Environment Temperature-40 Degrees Celsius60 Degrees Celsius

Contacts#

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

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00607411201509Salter Labs Adult, ETC02 Nasal Sampling Cannula, female luer style connecSO-165090122016-09-24
00607411001147AirLife1007-01007-0-102016-11-30
00607411001154AirLife1008-01008-0-102016-11-30
00607411001024AirLife1005-01005-0-252016-11-30
10607411001045AirLife1016-0-251016-0-252016-11-30
10607411891714AirLife1017-0-251017-0-252016-11-30
10607411001038AirLife1006-0-1001006-0-1002016-11-30
10607411891110AirLife1217-0-251217-0-252016-11-30
00607411001048AirLife1016-01016-02019-04-29
00607411919039Salter Labs® High Concentration partial rebreather131202026-06-10
00607411919077Salter Labs® Nasal Cannula133002026-06-10
00607411919091Salter Labs® Nasal Cannula133042026-06-10
00607411919121Salter Labs® Nasal Cannula133092026-06-10
00607411919190Salter Labs® Nasal Cannula133372026-06-10
00607411919213Salter Labs® Nasal Cannula133472026-06-10
00607411919268Salter Labs® Oxygen Tubing134092026-06-10
00607411919282Oxygen Tubing Swivel Connector134452026-06-10
00607411919336Salter Labs® Percent-O2-Lock® Mask138152026-06-10
00607411919343Salter Labs® Full Kit Nebulizer139502026-06-10
00607411919367Salter Labs® Full Kit Nebulizer Set139522026-06-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00607411919039Salter Labs® High Concentration partial rebreatherSALTER LABSBYG2026-06-10
00607411919336Salter Labs® Percent-O2-Lock® MaskSALTER LABSBYG2026-06-10
00607411919008Salter Labs® Adult Comfort Face TentSALTER LABSBYG2026-06-09
00607411919053Salter Labs® Oxygen MaskSALTER LABSBYG2026-06-09
00607411919060Salter Labs® Oxygen MaskSALTER LABSBYG2026-06-09
04816415501379LARYNGEAL MASK Single Use Size 2ASSOMEDIKA, OOOBYG2026-05-27
04816415501386LARYNGEAL MASK Single Use Size 3ASSOMEDIKA, OOOBYG2026-05-27
04816415501393LARYNGEAL MASK Single Use Size 5ASSOMEDIKA, OOOBYG2026-05-27
08697645018129ENDURE INDUSTRIESENDURE INDUSTRIESBYG2026-04-17
08697645018136ENDURE INDUSTRIESENDURE INDUSTRIESBYG2026-04-17
08697645018143ENDURE INDUSTRIESENDURE INDUSTRIESBYG2026-04-17
09420012427632Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBYG2026-03-18
09420012428585Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBYG2026-03-18
10885632467400HalyardOWENS & MINOR DISTRIBUTION, INC.BYG2026-01-29
10885632467417HalyardOWENS & MINOR DISTRIBUTION, INC.BYG2026-01-29
10885632467462HalyardOWENS & MINOR DISTRIBUTION, INC.BYG2026-01-29
10889483221662Performance Home MedicalSUNMED, LLCBYG2025-12-31
10889483227268BiFLo™SUNMED, LLCBYG2025-12-30
10889483227275BiFLo™SUNMED, LLCBYG2025-12-30
10889483223970AirLife™SUNMED, LLCBYG2025-12-19
10889483224151AirLife™SUNMED, LLCBYG2025-12-19
10889483224298DeVilbissSUNMED, LLCBYG2025-12-19
10889483224687AirLife™SUNMED, LLCBYG2025-12-19
10889483224168AirLife™SUNMED, LLCBYG2025-12-18
10197344011117HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
10197344011742HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
10197344011759HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
10197344011773HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
10197344042203HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
10197344011582HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-14