FDA.reportPublic FDA data

CompressAR StrongArm XL 3-FingerJack Stand

Primary DI
10815614020552
Brand
CompressAR StrongArm XL 3-FingerJack Stand
Company
Semler Technologies, Inc.
Model
1400
Catalog number
160-0004-01
Device description
The CompressAR StrongArm XL 3-FingerJack Stand is an extended length stand with a base plate for use with a Hill-Rom VersaCare® bed and is used with a CompressAR 3-FingerJack Disc, to provide hemostasis of the femoral vascular access site following femoral artery catheterization procedures.
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DXCClamp, Vascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXCClamp, VascularCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K002767000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K002767000COMPRESSAR FEMORAL ACCESS COMPRESSION DEVICESemler Technologies, Inc.2000-09-27DXC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10815614020552PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081561402055210815614020552

GMDN Terms#

Term, Definition table
TermDefinition
Femoral artery compression system, manual, reusableA 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. 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 is typically used following coronary angiography/ventriculography and PTCA; it may in addition be used on brachial and radial arteries or after venipuncture. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
042075700
Device count
1
Serial number
true
Manufacturing date on label
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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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10197344138890NAMICMEDLINE INDUSTRIES, INC.DXC2026-03-16
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08022057015907DeTACH Aortic Cross Clamp Head-SmallCORCYM SRLDXC2026-02-03
10193489727173Medline Industries, Inc.MEDLINE INDUSTRIES, INC.DXC2022-08-04
10195594150808CARDINAL HEALTHCardinal Health 200, LLCDXC2021-07-09
20884521152134CovidienCardinal Health, Inc.DXC2016-09-24
M20630300D-Stat® Clamp topical hemostat accessoryVascular Solutions, Inc.DXC2016-09-15
M20635240Vasc Band™ hemostatVascular Solutions, Inc.DXC2016-09-05
M20635270Vasc Band™ hemostatVascular Solutions, Inc.DXC2016-09-05
M20635290Vasc Band™ hemostatVascular Solutions, Inc.DXC2016-09-05
M20635370Vasc Band™ hemostatVascular Solutions, Inc.DXC2016-09-05
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