FDA.reportPublic FDA data

Apnea Guard

Primary DI
00851113007123
Brand
Apnea Guard
Company
ADVANCED BRAIN MONITORING, INC.
Model
AG25-4107.20
Device description
Apnea Guard Retention Material Kit 5.5g
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
ELWMaterial, Impression

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELWMaterial, ImpressionDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851113007123PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851113007123008511130071238511130071230851113007123

GMDN Terms#

Term, Definition table
TermDefinition
Silicone dental impression materialAn elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
969842715
Device count
1
Manufacturing date on label
true
Expiration date on label
true

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00850063034326Night ShiftNS27-1005.LE(NOR)2025-12-08
00850063034333Night ShiftNS27-1005.LE(SWE)2025-12-08
00850063034357Night ShiftNS27-1010.LE(FRE)2025-12-08
00850063034340Night ShiftNS27-1010.LE(ENSO)2025-11-14
70850015266194Night ShiftNS27-1005.LE(ENSO)2025-10-27
00850063034302Night ShiftNS27-1005.LE(DAN)2025-08-21
00850063034272Night ShiftNS27-41022025-07-21
00850063034289Night ShiftNS27-4102.XXL2025-07-21
00850015266492Night ShiftNS27-41022022-03-29
00850015266508Night ShiftNS27-4102.XXL2022-03-29
00850063034265Night ShiftNS27-1010.LE2025-05-22
00850063034135X-SeriesXS30-1015.LE2025-01-29
00850063034166X-SeriesXS30-1001.LE2025-01-29
00850063034180X-SeriesXS30-1007.LE2025-01-29
00850063034128Sleep ProfilerSP29-1015.LE2025-01-28
00850063034142Sleep Profiler PSG2SP29-1002.LE2025-01-28
00850063034159Sleep Profiler PSG2SP29-1006.LE2025-01-28

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