FDA.reportPublic FDA data

Hang&Go PAC

Primary DI
M640R99001170031
Brand
Hang&Go PAC
Company
RAND SPA
Model
003
Catalog number
R9900117
Device description
Kit for hyperthermic perfusion
Published
2022-06-22
Public version status
New
Distribution status
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
K161613000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161613000Hang&Go PACRand S.R.L.2016-12-28LGZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M640R99001170031PrimaryHIBCC0

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
M640R99000990021Ch24 round silicone catheter002R99000992026-09-22
M640R99001200051Hang&Go005R99001202023-11-28
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
M640R99000990012Ch24 round silicone catheter001R99000992020-04-20
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
B286DWC243074TGRMB1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-10-05
B286SWC243074MBST1Single Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-09-30
B286DWC183074TLG4B1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-09-18
B286DWC182464TG4B220C1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-27
B286DWC243064T4BR21Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-27
B286DWC243074TGLHMB1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-27
B286DWC243074TGMB220C1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-27
B286DWC243074TGMBAVT1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-27
B286DWC243074TMBAVT1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-27
B286DWC243074TMBEL220C1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-27
B286DWC243074TTS4B1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-27
B286SWC1518224B1Single Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-27
B286SWC151822LHNB1Single CHAMBER WARMING CABINETM.A.C. MEDICAL INC.LGZ2026-08-21
B286SWC242424GNB1Single CHAMBER WARMING CABINETM.A.C. MEDICAL INC.LGZ2026-08-21
B286DWC183074EG4BC1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286DWC183074EGMB220C1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286DWC183074T4BAVT1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286DWC183074T4BR21Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286DWC183074TGMB220C1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286DWC183074TTS4B1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286DWC242464T4B1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286DWC242464TMB1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286DWC242474EGMB220C1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286DWC242474TG4BR21Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286DWC242474TG4BR2SB1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286243074TGMB1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-17
B286SWC242464GMB1single Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-14
00841027105749Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2026-07-24
00841027105725Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2026-07-12
00841027104766Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2026-06-02