Flow Control Tubing

Primary DI
09350902001133
Brand
Flow Control Tubing
Company
GO MEDICAL INDUSTRIES PTY. LTD.
Model
FCT 30mL/96h
Catalog number
FCT30-96h
Published
2017-05-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FRNPump, Infusion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRNPump, InfusionGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K910007000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K910007000SPRINGFUSOR 10RGo Medical Industries Pty. , Ltd.1993-11-02FRN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09350902001126PackageGS125In Commercial Distribution
09350902001133PackageGS1300In Commercial Distribution
09350902001119PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09350902001126093509020011269350902001126
09350902001133093509020011339350902001133
09350902001119093509020011199350902001119

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
757634266
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09350902000396Flow Control TubingFCT 10mL/5minFCT10-5m2016-09-24
09350902000426Flow Control TubingFCT 10mL/15minFCT10-15m2016-09-24
09350902000457Flow Control TubingFCT 10mL/30minFCT10-30m2016-09-24
09350902000488Flow Control TubingFCT 10mL/60minFCT10-60m2016-09-24
09350902000518Flow Control TubingFCT 10mL/2hFCT10-2h2016-09-24
09350902000549Flow Control TubingFCT 10mL/4hFCT10-4h2016-09-24
09350902000570Flow Control TubingFCT 10mL/6hFCT10-6h2016-09-24
09350902000600Flow Control TubingFCT 10mL/8hFCT10-8h2016-09-24
09350902000631Flow Control TubingFCT 10mL/12hFCT10-12h2016-09-24
09350902000662Flow Control TubingFCT 10mL/24hFCT10-24h2016-09-24
09350902000693Flow Control TubingFCT 10mL/48hFCT10-48h2016-09-24
09350902000723Flow Control TubingFCT 10mL/72hFCT10-72h2016-09-24
09350902000754Flow Control TubingFCT 30mL/5minFCT30-5m2017-05-16
09350902000785Flow Control TubingFCT 30mL/15minFCT30-15m2017-05-16
09350902000815Flow Control TubingFCT 30mL/30minFCT30-30m2017-05-16
09350902000846Flow Control TubingFCT 30mL/60minFCT30-60m2017-05-16
09350902000877Flow Control TubingFCT 30mL/2hFCT30-2h2017-05-16
09350902000907Flow Control TubingFCT 30mL/4hFCT30-4h2017-05-16
09350902000938Flow Control TubingFCT 30mL/6hFCT30-6h2017-05-16
09350902000969Flow Control TubingFCT 30mL/8hFCT30-8h2017-05-16

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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
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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
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