FDA.reportPublic FDA data

Orantech

Primary DI
06941691959984
Brand
Orantech
Company
Orantech Inc.
Model
BPH-AS35-02M-02M
Device description
Spacelabs Compatible, Adult/Pediatric, Single tube, 3.5m
Published
2022-10-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JFCSystem, Pressure Measurement, Intermittent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JFCSystem, Pressure Measurement, IntermittentPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06941691959984PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06941691959984069416919599846941691959984

GMDN Terms#

Term, Definition table
TermDefinition
External cuff/pad connection tubingA length of flexible tube intended to be used to deliver air and/or fluid from a pump to a noninvasive, patient-contact pad, pack or cuff. It may be intended for use with a specific type of assembly (e.g., circulating-air/fluid thermal therapy system, electronic sphygmomanometer, venous compression system). It is typically made of synthetic material and may be intended to be permanently attached to the system control unit. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544423370
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970706360668ETCO2 SensorCTM-RP012020-12-25
06941691934233Orantech ET-3005R-PH-A2026-01-29
06941691934240Orantech ET-3005R-PH-I2026-01-29
06941691938279Orantech EL-PH3-90G-A2026-01-29
06941691948865Orantech EL-PH3-90G-I2026-01-29
06941691983132Orantech IBP-KR-MD0172026-01-29
06941691905431Orantech IBP-PH-2MIR402026-01-16
06941691982906Orantech IBP-GE-MD0172026-01-16
06941691982913Orantech IBP-SL-MD0172026-01-16
06941691982920Orantech IBP-NKB-MD0172026-01-16
06941691982937Orantech IBP-NKC-MD0172026-01-16
06941691982944Orantech IBP-DGB-MD0172026-01-16
06941691982951Orantech IBP-DGC-MD0172026-01-16
06941691982968Orantech IBP-DGD-MD0172026-01-16
06941691982975Orantech IBP-DGE-MD0172026-01-16
06941691982982Orantech IBP-MRB-MD0172026-01-16
06941691982999Orantech IBP-CR-MD0172026-01-16
06941691983002Orantech IBP-BLT-MD0172026-01-16
06941691983019Orantech IBP-KTN-MD0172026-01-16
06941691983026Orantech IBP-CL-MD0172026-01-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260242060217DIERS pedoscanDIERS International GmbHJFC2026-03-09
05425026002008Materialise Footscan Pro Level pressure plateMaterialise MotionJFC2026-01-31
05425026002015Materialise Footscan Pro Level pressure plateMaterialise MotionJFC2026-01-31
05425026002046Materialise Footscan Pro Level pressure plateMaterialise MotionJFC2026-01-31
05425026002053Materialise Footscan Pro Level pressure plateMaterialise MotionJFC2026-01-31
05391550080006Danu DANU SPORTS LIMITEDJFC2025-12-17
06941691920540Orantech Orantech Inc.JFC2024-12-17
06941691921134Orantech Orantech Inc.JFC2024-12-17
06941691909620Orantech Orantech Inc.JFC2024-12-05
06941691909736Orantech Orantech Inc.JFC2024-12-05
06941691910022Orantech Orantech Inc.JFC2024-12-05
06941691910619Orantech Orantech Inc.JFC2024-12-05
06941691910688Orantech Orantech Inc.JFC2024-12-05
06941691911425Orantech Orantech Inc.JFC2024-12-05
06941691982289Orantech Orantech Inc.JFC2024-12-05
06941691982296Orantech Orantech Inc.JFC2024-12-05
03760349820055FeetMe Monitor FTM-DKFEETMEJFC2023-03-24
07540150603308BodiTrakVista Medical LtdJFC2022-12-13
07540150603780BodiTrakVista Medical LtdJFC2022-12-13
03760349820048FeetMe Monitor FTM-DKFEETMEJFC2022-11-11
B970303012503030-125 SensorTekscan, Inc.JFC2020-11-04
B9703000E12503000-E-125 F-Scan SensorTekscan, Inc.JFC2020-11-03
B9703000E5003000-E-50 F-Scan SensorTekscan, Inc.JFC2020-11-03
B9703000ES03000-E-S F-Scan SensorTekscan, Inc.JFC2020-11-03
B9703000SPORTE12503000SPORT-E-125 F-Scan SensorTekscan, Inc.JFC2020-11-03
B9703000SPORTE5003000SPORT-E-50 F-Scan SensorTekscan, Inc.JFC2020-11-03
B9703000SPORTES03000SPORT-E-S F-Scan SensorTekscan, Inc.JFC2020-11-03
B9703001E12503001-E-125 F-Scan SensorTekscan, Inc.JFC2020-11-03
B9703001ES03001-E-S F-Scan SensorTekscan, Inc.JFC2020-11-03
B9703001SPORTE12503001SPORT-E-125 F-Scan SensorTekscan, Inc.JFC2020-11-03