Reflux Band Pressure Sensor

Primary DI
00866736000383
Brand
Reflux Band Pressure Sensor
Company
The Reflux Company
Model
101-1290-00
Device description
Pressure transducer used in fitting the Reflux Band.
Published
2026-10-08
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IKETransducer, Miniature Pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKETransducer, Miniature PressurePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00866736000383PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00866736000383008667360003838667360003830866736000383

GMDN Terms#

Term, Definition table
TermDefinition
Pressure transducer dome, single-useA sterile plastic housing that connects together with an external pressure transducer (not included),, forming a measuring compartment. The transducer is influenced by the pressure of the medium, e.g., blood directly from a patient, that is channelled into the compartment, thereby creating the signals. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
858-397-2200contact@refluxcompany.com

Regulatory Flags#

DUNS number
144845049
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00866736000307Reflux Band101-1170-002026-10-08
00866736000314Reflux Band Manometer101-250-002026-10-08
00899994002097RestechDx-201 pH probe CAS2022-12-02
00899994002103RestechDx-10002022-12-02
00899994002110RestechDx-3002022-12-02
00899994002127RestechDx-5002022-12-02
00899994002134RestechDx-201 P2022-12-02
00899994002141RestechDx-201 L 2022-12-02
00856219002102Mederi MDRF1 GeneratorMDRF1177-51502016-09-27
00856219002294Stretta8800175-55802016-09-27
00856219002003Secca8000175-51072016-09-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00866736000314Reflux Band ManometerThe Reflux CompanyIKE2026-10-08
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10810091040246IOPI®Iopi Medical LLCIKE2025-03-21
10810091040284IOPI®Iopi Medical LLCIKE2025-03-21
10810091040253IOPI®Iopi Medical LLCIKE2025-03-21
10810091040277IOPI®Iopi Medical LLCIKE2025-03-21
10810091040291IOPI®Iopi Medical LLCIKE2025-03-21
00816271020797myoRESEARCHNoraxon U.S.A., Inc.IKE2023-06-07
10810091040031IOPI®Iopi Medical LLCIKE2022-10-20
10810091040048IOPI®Iopi Medical LLCIKE2022-10-20
10810091040055IOPI®Iopi Medical LLCIKE2022-10-20
10810091040000IOPI®Iopi Medical LLCIKE2022-10-20
10810091040024IOPI®Iopi Medical LLCIKE2022-10-20
10810091040062IOPI®Iopi Medical LLCIKE2022-10-20