FDA.reportPublic FDA data

Ch24 round silicone catheter

Primary DI
M640R99000990012
Brand
Ch24 round silicone catheter
Company
RAND SPA
Model
001
Catalog number
R9900099
Published
2020-04-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GBXCatheter, Irrigation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBXCatheter, IrrigationGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M640R99000990012PackageHIBCC10In Commercial Distribution
M640R99000990013PackageHIBCC4In Commercial Distribution
M640R99000990014PackageHIBCC2In Commercial Distribution
M640R99000990011PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Multi-purpose percutaneous drainage catheterA sterile flexible tube intended for percutaneous introduction into two or more abdominothoracic anatomies (nephrostomy, biliary, abscess, pleural, peritoneal, mediastinal) [i.e., multi-purpose] for intermittent or long-term drainage. It is available in various designs, shapes, and sizes, and is often designed to be connected to a pleural/peritoneal cavity suction (drainage) system. It may include disposable devices dedicated to catheter introduction. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge24French
Length600Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius35 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
655010531
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M640R99001200051Hang&Go005R99001202023-11-28
M640R99001170031Hang&Go PAC003R99001172022-06-22
M640R99000990011Ch24 round silicone catheter001R99000992020-04-20
M640R99001170021Hang&Go PAC002R99001172021-02-12
M640R99000900011Hang&Go HT Basic 001R99000902020-07-23
M640R99001170011Hang&Go PAC001R99001172020-07-23
M640R99001200021Hang&Go002R99001202020-07-23
M640R99001200031Hang&Go003R99001202020-07-23
M640R99000990001Ch24 round silicone catheter000R99000992017-01-27
M640R99000900021Hang&Go HT Basic 002R99000902021-02-12
M640R99001200041Hang&Go004R99001202021-02-12
M640R99001200011Hang&Go001R99001202020-04-27
M640R99000900001Hang&Go HT Basic 000R99000902017-01-27
M640R99001170001Hang&Go PAC000R99001172017-02-21
M640R51000710041Performer HT004R51000712020-04-27
M640R51000710031Performer HT003R51000712018-09-07
M640R99001200001Hang&Go000R99001202017-01-09
M640R51000710001Performer HT000R51000712017-01-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450022146One-Step™Merit Medical Systems, Inc.GBX2026-07-29
00884450022160One-Step™Merit Medical Systems, Inc.GBX2026-07-29
00884450022184One-Step™Merit Medical Systems, Inc.GBX2026-07-29
00884450022306One-Step™Merit Medical Systems, Inc.GBX2026-07-29
00884450022313One-Step™Merit Medical Systems, Inc.GBX2026-07-29
00884450022535One-Step™Merit Medical Systems, Inc.GBX2026-07-29
00884450022559One-Step™Merit Medical Systems, Inc.GBX2026-07-29
00884450022566One-Step™Merit Medical Systems, Inc.GBX2026-07-29
00884450022573One-Step™Merit Medical Systems, Inc.GBX2026-07-29
00884450022597One-Step™Merit Medical Systems, Inc.GBX2026-07-29
00884450022603One-Step™Merit Medical Systems, Inc.GBX2026-07-29
00884450022665One-Step™Merit Medical Systems, Inc.GBX2026-07-29
00884450022689One-Step™Merit Medical Systems, Inc.GBX2026-07-29
00884450022764One-Step™Merit Medical Systems, Inc.GBX2026-07-29
00884450024010One-Step™Merit Medical Systems, Inc.GBX2026-07-29
00884450024027One-Step™Merit Medical Systems, Inc.GBX2026-07-29
00840456202692JMUJMU DENTAL, INCGBX2026-07-27
00840456202708JMUJMU DENTAL, INCGBX2026-07-27
00884450014523ReSolve®, StayFIX®,Merit Medical Systems, Inc.GBX2026-07-16
00840456216750JMUJMU DENTAL, INCGBX2026-06-22
00840456216767JMUJMU DENTAL, INCGBX2026-06-22
00840456216774JMUJMU DENTAL, INCGBX2026-06-22
17350128050006LinkUS DrainInterlinked ABGBX2026-05-31
10080196995998MEDLINEMEDLINE INDUSTRIES, INC.GBX2024-12-12
10080196128839MedlineMEDLINE INDUSTRIES, INC.GBX2023-12-27
10080196997633MedlineMEDLINE INDUSTRIES, INC.GBX2023-12-27
08034139292823Thoracic Catheter, Straight Fr 18REDAX SPAGBX2021-05-07
08034139292830Thoracic Catheter, Straight Fr 21REDAX SPAGBX2021-05-07
08034139292847Thoracic Catheter, Straight Fr 24REDAX SPAGBX2021-05-07
08034139292861Thoracic Catheter, Straight Fr 30REDAX SPAGBX2021-05-07