3.0 Liter Reservoir (1 Piece)

Primary DI
00896128002008
Brand
3.0 Liter Reservoir (1 Piece)
Company
BELMONT INSTRUMENT CORPORATION
Model
903-00018P
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FRNPump, Infusion
LGZWarmer, Thermal, Infusion Fluid

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141654000
K242735000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141654000THE BELMONT RAPID INFUSERBelmont Instrument Corporation2014-07-18FRN
K242735000Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min); Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 750 ml/min)Belmont Medical Technologies2024-12-23FRN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00896128002008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00896128002008008961280020088961280020080896128002008

GMDN Terms#

Term, Definition table
TermDefinition
Heat-exchanging intravenous administration setA collection of noninvasive devices designed to directly warm and conduct fluids from an intravenous (IV) administration bag/bottle to a peripheral venous cannula (not included) during gravitational or pump administration to a patient's venous system. It typically includes tubing, connectors, chambers, and clamps; the bag/bottle may be included. It does not include devices intended to be used invasively. 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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