FDA.reportPublic FDA data

ComfortPress Hand-Held Vascular Compression Assist Device

Primary DI
10815614020033
Brand
ComfortPress Hand-Held Vascular Compression Assist Device
Company
Semler Technologies, Inc.
Model
3100-13
Catalog number
130-0100-13
Device description
The ComfortPress Hand-Held Vascular Compression Assist Device is an ergonomic, sterile, disposable external compression device. ComfortPress is designed to enhance comfort for the practitioner and the patient when applying external compression of the femoral artery. Practitioners apply external pressure using ComfortPress in much the same way that they would when applying manual pressure. The Model 3100-13 is a small sterile molded handle fitted with a Large SuperComfort™ Disc in a sealed package. This is a single use device.
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
DXCClamp, Vascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXCClamp, VascularCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K072167000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072167000COMFORTPRESS VASCULAR COMPRESSION ASSIST DEVICEAdvanced Vascular Dynamics2007-09-06DXC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20815614020030PackageGS120In Commercial Distribution
10815614020033PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2081561402003020815614020030
1081561402003310815614020033

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.

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
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
10815614020378Zephyr Vascular Compression Device9100-00190-0100-002016-09-24

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Primary DI, Brand, Company table
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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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