SMALL D-RING CUFF

Primary DI
00073796392437
Brand
SMALL D-RING CUFF
Company
Omron Healthcare, Inc.
Model
HEM-CS24-C
Device description
The HEM-CS24-C is a reusable Small D-Ring upper-arm cuff accessory intended for use with compatible OMRON blood pressure monitors. The cuff is designed for users with an upper arm circumference of 7 to 9 inches (17 to 22 cm). The cuff consists of a fabric cuff, inflatable bladder, air tube, and air plug. During use, the cuff is wrapped around the upper arm and connected to the blood pressure monitor through the air plug. When a measurement is initiated, the monitor inflates and deflates the cuff to temporarily occlude and then release the brachial artery. The cuff transfers the pressure changes generated during the measurement process to the monitor, which performs the blood pressure and pulse rate calculations. The HEM-CS24-C is a non-powered accessory and contains no electronics, software, wireless communication functions, or user-configurable settings.
Published
2026-07-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXNSystem, Measurement, Blood-Pressure, Non-Invasive
DXQBlood Pressure Cuff

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2
DXQBlood Pressure CuffCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133379000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133379000HEM-7311Omron Healthcare, Inc.2014-01-16DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00073796392437PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00073796392437000737963924370737963924370073796392437

GMDN Terms#

Term, Definition table
TermDefinition
Blood pressure cuff, reusableA band-like device that has an inflatable bladder in an inelastic sleeve with one or two connecting tubes with connector (typically locking connectors) that can be connected to a mechanism for inflating and deflating the bladder and/or a sphygmomanometer or a patient monitoring device/system that is used to determine a patient's blood pressure. It is wrapped around the upper arm or the leg (thigh) of the patient. This is a reusable device which may be intended for single-patient or multi-patient reuse.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure00
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
8006344350ohiquality@omron.com

Regulatory Flags#

DUNS number
054318779
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
false
Sterilization required before use
false

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Primary DI, Brand, Model table
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Primary DI, Brand, Company table
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