FDA.reportPublic FDA data

HIgH-Flo™, RMS Precision Flow Rate TubingTM

Primary DI
00659443000698
Brand
HIgH-Flo™, RMS Precision Flow Rate TubingTM
Company
REPRO MED SYSTEMS, INC.
Model
FEXT
Catalog number
FEXT
Device description
"24"" Tubing Extender"
Published
2016-08-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRNPump, infusion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRNPump, InfusionGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10659443000695PackageGS120In Commercial Distribution
00659443000698PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1065944300069510659443000695
00659443000698006594430006986594430006980659443000698

GMDN Terms#

Term, Definition table
TermDefinition
Mechanical infusion pump administration setA collection of devices intended to be used with a mechanical infusion pump (non-electric) to enable the intermittent or continuous infusion of medication (not included), typically for antibiotic therapy, chemotherapy, or pain management [including patient-controlled analgesia (PCA)] by intravenous (IV), subcutaneous, intramuscular, or epidural routes. It typically consists of a reservoir (e.g., a plastic pouch), plastic tubing, a check valve, a line clamp, and Luer connectors. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length24Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperature
Storage Environment Temperature16 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(845)610-5587fma@rmsmedpro.com

Regulatory Flags#

DUNS number
048403299
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00659443000230HIgH-Flo™ Needle SetRMS12604RMS126042016-08-19
00659443000247HIgH-Flo™ Needle SetRMS12609RMS126092016-08-19
00659443000254HIgH-Flo™ Needle SetRMS12606RMS126062016-08-19
00659443000261HIgH-Flo™ Needle SetRMS12612RMS126122016-08-19
00659443000278HIgH-Flo™ Needle SetRMS12614RMS126142016-08-19
00659443000285HIgH-Flo™ Needle SetRMS22604RMS226042016-08-19
00659443000292HIgH-Flo™ Needle SetRMS22606RMS226062016-08-19
00659443000308HIgH-Flo™ Needle SetRMS22609RMS226092016-08-19
00659443000315HIgH-Flo™ Needle SetRMS22612RMS226122016-08-19
00659443000322HIgH-Flo™ Needle SetRMS22614RMS226142016-08-19
00659443000339HIgH-Flo™ Needle SetRMS32604RMS326042016-08-19
00659443000346HIgH-Flo™ Needle SetRMS32606RMS326062016-08-19
00659443000353HIgH-Flo™ Needle SetRMS32609RMS326092016-08-19
00659443000360HIgH-Flo™ Needle SetRMS32612RMS326122016-08-19
00659443000377HIgH-Flo™ Needle SetRMS32614RMS326142016-08-19
00659443000384HIgH-Flo™ Needle SetRMS42604RMS426042016-08-19
00659443000391HIgH-Flo™ Needle SetRMS42606RMS426062016-08-19
00659443000407HIgH-Flo™ Needle SetRMS42609RMS426092016-08-19
00659443000414HIgH-Flo™ Needle SetRMS42612RMS426122016-08-19
00659443000421HIgH-Flo™ Needle SetRMS42614RMS426142016-08-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08500835120017Avoset Optum Homecare InfusionOptum Distribution Center, LLCFRN2026-02-24
17290109155309Sapphire M.T. Pump Kit CEITAN MEDICAL LTDFRN2024-09-04
30815112021345Elution Test Vial Bracco Diagnostics Inc.FRN2024-02-13
10815112021396CardioGen-82 Infusion System Model 1700Bracco Diagnostics Inc.FRN2023-12-01
10815112021358CardioGen Patient Administration SetBracco Diagnostics Inc.FRN2023-10-16
17290109155149Sapphire Epidural Infusion Kit - US EITAN MEDICAL LTDFRN2023-09-05
30815112021338Accessory PackageBracco Diagnostics Inc.FRN2023-06-29
30815112020034Accessory PackageBracco Diagnostics Inc.FRN2023-03-22
30815112020614Accessory PackageBracco Diagnostics Inc.FRN2023-03-22
17290109154272Sapphire Epidural Infusion Pump Kit – USEITAN MEDICAL LTDFRN2022-05-15
17290109154289Sapphire M.T Infusion Pump Kit- US - S kit EITAN MEDICAL LTDFRN2022-05-15
17290109154265Sapphire M.T Infusion Pump Kit – USEITAN MEDICAL LTDFRN2022-05-11
10814844000365Curlin IV Pump SystemZEVEX INTERNATIONAL, INC.FRN2021-04-29
15019517177367PharmGuardICU MEDICAL, INC.FRN2020-03-20
15019517177374PharmGuardICU MEDICAL, INC.FRN2020-03-20
10884521064843KangarooCardinal Health, Inc.FRN2019-12-30
15019517155143MEDFUSIONICU MEDICAL, INC.FRN2019-09-20
15019517155150MEDFUSIONICU MEDICAL, INC.FRN2019-09-20
15019517155167MEDFUSIONICU MEDICAL, INC.FRN2019-09-20
15019517178067MedfusionICU MEDICAL, INC.FRN2019-09-18
20763000273334MiniMed™ ReservoirMEDTRONIC MINIMED, INC.FRN2019-09-02
20763000273358MiniMed™ ReservoirMEDTRONIC MINIMED, INC.FRN2019-09-02
M33513852011Plum 360ICU MEDICAL, INC.FRN2019-02-15
70643169771481MiniMed™ ReservoirMEDTRONIC MINIMED, INC.FRN2018-05-31
08050616611635APO-GO Syringe reservoirCANE' SPAFRN2018-05-28
17290109150229SapphirePlus Infusion Kit - USEITAN MEDICAL LTDFRN2018-02-22
09350902001614Flow Control TubingGO MEDICAL INDUSTRIES PTY. LTD.FRN2017-05-18
09350902001690Flow Control TubingGO MEDICAL INDUSTRIES PTY. LTD.FRN2017-05-18
09350902001720Flow Control TubingGO MEDICAL INDUSTRIES PTY. LTD.FRN2017-05-18
09350902001751Flow Control TubingGO MEDICAL INDUSTRIES PTY. LTD.FRN2017-05-18