FDA.reportPublic FDA data

N/A

Primary DI
20607411800874
Brand
N/A
Company
SALTER LABS
Model
1107-0
Catalog number
1107-0
Device description
I-Guard™ Aerosol Mask (Pediatric) 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
OTC
false
Sterile
false
Single use
false

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
10607411800877PackageGS110In Commercial Distribution
20607411800874PackageGS150In Commercial Distribution
00607411800870PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060741180087710607411800877
2060741180087420607411800874
00607411800870006074118008706074118008700607411800870

GMDN Terms#

Term, Definition table
TermDefinition
Aerosol face mask, non-rebreathingA flexible, form-shaped device that is placed over the nose and mouth to deliver air, oxygen (O2), or a mixture of the two gases, with aerosolized particles, to a patient's airway. It includes two unidirectional valves, one that closes during inspiration to prevent room air from mixing with the O2 in the reservoir bag, and one that closes during exhalation to prevent exhaled respiratory gases from entering the reservoir bag. It is made of high-grade resins or other materials to produce a soft, flexible mask that will create an airtight seal against the patient's face. It typically includes a headstrap and is available in a range of sizes. 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

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
true
HCT/P
false
Kit
true
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00607411966378IntuBrite SterileS01-6015.CS01-6015.C2018-12-13
00607411966385IntuBrite SterileS01-6016.CS01-6016.C2018-12-13
00607411966392IntuBrite SterileS01-6017.CS01-6017.C2018-12-13
00607411973055AirLifeSO-2169-0SO-2169-02026-05-11
00607411973062AirLifeSO-2170-0SO-2170-02026-05-11
10607411007344Sticky WhiskersSW102-0-25SW102-0-252016-09-24
00607411200915N/AL7600-0L7600-02016-09-24
00607411300738AirLifeSO-1500-0SO-1500-02016-11-30
00607411889097AirLifeSO-1188-0SO-1188-02016-11-30
00607411889103AirLifeSO-1189-0SO-1189-02016-11-30
00607411889110AirLifeSO-1190-0SO-1190-02016-11-30
00607411918025AirLifeSO-1968-0SO-1968-02016-11-30
00607411918070AirLifeSO-1972-0SO-1972-02016-11-30
00607411102035Salter Labs8107V-02026-04-24
00607411800870N/A1107-01107-02016-11-30
00607411001017N/A1003-0-501003-0-502016-12-16
10607411976237NebuTech8990TG-7-508990TG-7-502023-09-25
10607411001229Salter AIRE Elite8501-0-58501-0-52018-02-09
00607411001611N/ASO-461SO-4612016-09-24
00607411102103Salter AIRE Elite8352-8924-7-18352-8924-7-12016-09-24

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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10197344010646HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-06