FDA.reportPublic FDA data

Hang&Go HT Basic

Primary DI
M640R99000900001
Brand
Hang&Go HT Basic
Company
RAND SPA
Model
000
Catalog number
R9900090
Device description
Kit for hyperthermic perfusion
Published
2017-01-27
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LGZWarmer, Thermal, Infusion Fluid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LGZWarmer, Thermal, Infusion FluidGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K120026000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120026000PERFORMER HT/ HANG&GO HT BASICRand S.R.L.2012-05-08LGZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M640R99000900001PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Intravascular/intracavitary-circulation hyperthermia system setA collection of sterile devices used with an intravascular/intracavitary-circulation hyperthermia system for the circulation of blood/fluids, with or without added chemotherapeutic agents, between the patient and the system's extracorporeal circuit during cancer therapy. It typically consists of drains/catheters, tubing, connectors, manual clamps, and hard or soft reservoirs; some types may include in-line filters, an oxygenator, and temperature sensors. This is a single-use device.

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
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

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
M640R99001170001Hang&Go PAC000R99001172017-02-21
M640R51000710041Performer HT004R51000712020-04-27
M640R99000990012Ch24 round silicone catheter001R99000992020-04-20
M640R51000710031Performer HT003R51000712018-09-07
M640R99001200001Hang&Go000R99001202017-01-09
M640R51000710001Performer HT000R51000712017-01-25

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