FDA.reportPublic FDA data

Hyperthermia Pump Y-Set Pt Line, 4.4L Reservoir

Primary DI
00896128002473
Brand
Hyperthermia Pump Y-Set Pt Line, 4.4L Reservoir
Company
BELMONT INSTRUMENT CORPORATION
Model
902-00047P
Published
2016-09-23
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
K152208000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152208000The Belmont Hyperthermia PumpBelmont Instrument Corporation2015-09-02LGZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00896128002473PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00896128002473008961280024738961280024730896128002473

GMDN Terms#

Term, Definition table
TermDefinition
Extravascular-circulation hyperthermia system applicator, intracorporealA component of a hyperthermia system that typically consists of catheter-enclosed tubing which is introduced into the body either manually or endoscopically. Heated fluid is circulated through the applicator's tubing for localized heating to treat malignant tumours, benign growths, or other disease-related conditions. The applicator (also called an interstitial applicator or probe) typically includes a thermometry component that monitors the temperature of the applicator during operation; it also includes tubing, cables, and connectors that interface with the hyperthermia system's control unit during treatments. It is typically used in an oncology department. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078330362
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
17290012127332CureWrap™ Pediatric, 79-91cm (8 pack)500-03531500-035312016-09-24
07290012127175CureWrap™ Adult Over 135 cm500-03500500-035002016-09-24
07290012127182CureWrap™ Infant, 2.5-4Kg500-03518500-035182016-09-24
07290012127199CureWrap™ Infant, 4-7Kg (single)500-03521500-035212016-09-24
07290012127328CureWrap™ Infant, 7-11Kg, (single)500-03525500-035252016-09-24
07290012127342CureWrap™ Pediatric 91-104cm, (single) 500-03536500-035362016-09-24
07290012127380 CureWrap™ Pediatric 122–135cm (single)500-03548500-035482016-09-24
07290107580625CureWrap™Infant (single)500-T35182016-09-24
07290012127205ThermoWrap™ Universal 79–91cm (single)500-03131500-031312016-09-24
07290012127212ThermoWrap™ Universal, 91–104cm (single)500-03136500-031362016-09-24
07290012127229ThermoWrap™ Universal, 104–122cm (single)500-03141500-031412016-09-24
07290012127236ThermoWrap™ Pediatric, 122–135cm, (single)500-03148500-031482016-09-24
07290012127243ThermoWrap™ Universal 135-152cm, (single)500-03153500-031532016-09-24
07290012127250ThermoWrap™ Universal 152-168cm (single) 500-03160500-031602016-09-24
07290012127267ThermoWrap™ Universal, Adults, 168-180cm, (single)500-03166500-031662016-09-24
07290012127274ThermoWrap™ Cardiac 165-172cm, (single)500-03363500-033632016-09-24
07290012127281ThermoWrap™ Infant, 2.5–4.0Kg,(single)500-03118500-031182016-09-24
07290012127298ThermoWrap™ Infant, 4.0–7.0Kg, (single)500-03121500-031212016-09-24
07290012127304ThermoWrap™ Infant, 7.0–11Kg, (single)500-03125500-031252016-09-24
07290012127373 CureWrap™ Pediatric 104–122cm (single) 500-03541500-035412016-09-24

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