FDA.report

Orantech

Primary DI
06941691964889
Brand
Orantech
Company
Orantech Inc.
Model
BPH-AS25-19-02M
Device description
FUKUDA Compatible, Adult/Pediatric, Single tube, 2.5m
Published
2022-10-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
JFCSystem, Pressure Measurement, Intermittent

Product Code Classifications

CodeDeviceSpecialtyClass
JFCSystem, Pressure Measurement, IntermittentPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06941691964889PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06941691964889069416919648896941691964889

GMDN Terms

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

Regulatory Flags

DUNS number
544423370
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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06941691982968Orantech IBP-DGD-MD0172026-01-16
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06941691982999Orantech IBP-CR-MD0172026-01-16
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06941691983019Orantech IBP-KTN-MD0172026-01-16
06941691983026Orantech IBP-CL-MD0172026-01-16
06941691983033Orantech IBP-MEK-MD0172026-01-16

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