FDA.reportPublic FDA data

CompressAR Large Round Disc

Primary DI
10815614020187
Brand
CompressAR Large Round Disc
Company
Semler Technologies, Inc.
Model
5123
Catalog number
150-0123-06
Device description
"The CompressAR Large Round Disc is a sterile, single use product that is attached to the CompressAR System Stand to apply compression to the femoral artery during hemostasis. The Model 5123 is a large, round flat disc (2"" dia.)."
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DQOCatheter, Intravascular, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQOCatheter, Intravascular, DiagnosticCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K831337000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K831337000COMPRESSAR DISPOSABLE DISCInstromedix, Inc.1983-07-19DQO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20815614020184PackageGS112In Commercial Distribution
30815614020181PackageGS112In Commercial Distribution
10815614020187PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2081561402018420815614020184
3081561402018130815614020181
1081561402018710815614020187

GMDN Terms#

Term, Definition table
TermDefinition
Femoral artery compression system, manual, single-useA noninvasive, non-powered device intended to provide compression for haemostasis to the puncture site on a patient having undergone femoral artery catheterization, typically as an alternative to direct hand pressure; it may in addition be used on brachial and radial arteries or after venipuncture. The compressing portion could be one of a variety of designs (e.g., disc affixed to a handle, ball, dome or roller, manually-inflatable bulb) and is typically held in place with a frame, bandage, or straps secured around the patient's hips/thigh. It may be used in conjunction with dressings/haemostatic agents (not included). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
042075700
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10815614020156mBrace Wrist Support with Hook4250140-0250-002022-11-17
10815614020163mBrace Wrist Support with Clip4275140-0275-002022-11-17
10815614020170Wrist Assist Wrist Support4300140-0300-002022-11-17
10815614020262FlexBoard Wrist Support4400140-0400-002022-11-17
10815614020347WristAssist4300M140-0300-00-M2022-11-17
10815614021092mBrace 4285 Wrist Support with Hook4285140-0285-002025-02-27
10815614021085mBrace 4280 Wrist Support4280140-0280-002024-02-01
10815614020125mBrace Wrist Support4200140-0200-002022-11-15
10815614021115Elevate ArmBoard Extender H8100-EXTH180-0100-EXTH2025-05-19
10815614021122Elevate ArmBoard Extender H 8100-EXTH-U180-0100-EXTH-U2025-05-19
10815614020002CompressAR Compass Hand-Held Vascular Compression Assist Device3000130-0000-012016-09-24
10815614020804StatGuard Hemostatic Patch3010-00480-3010-002019-08-07
10815614020811StatGuard Hemostatic Dressing, Small3020-10480-3020-102018-09-27
10815614020828StatGuard Hemostatic Dressing, Regular3020-20480-3020-202019-02-28
10815614020033ComfortPress Hand-Held Vascular Compression Assist Device3100-13130-0100-132016-09-24
10815614020071RadAR Vascular Compression Device4150140-0150-002016-09-24
10815614020088RadAR Vascular Compression Device4160140-0160-002016-09-24
10815614020095RadAR EasyClik Vascular Compression Device4180140-0180-002016-09-24
10815614020118RadAR EasyClik Vascular Compression Device4185140-0185-002019-12-10
10815614020354ClampEase P-Series DiscP-700150-2031-702016-09-24

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00816777025913Sofia 5F-125cm STRMicrovention, Inc.DQO2018-08-07
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08714729200567Wiseguide ™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
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08714729200581Wiseguide ™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729200598Wiseguide ™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
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08714729200611Wiseguide ™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729200628Wiseguide ™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729200635Wiseguide ™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729200659Wiseguide ™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
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