FDA.report

HIgH-Flo™, RMS Precision Flow Rate TubingTM

Primary DI
10659443000695
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
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
FRNPump, infusion

Product Code Classifications

CodeDeviceSpecialtyClass
FRNPump, InfusionGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10659443000695PackageGS120In Commercial Distribution
00659443000698PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1065944300069510659443000695
00659443000698006594430006986594430006980659443000698

GMDN Terms

TermDefinition
Mechanical infusion pump administration setA collection of sterile devices intended to be used with a mechanical infusion pump (non-electric) to enable the intermittent or continuous infusion of medication, 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

TypeValueUnit
Length24Inch

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperature
Storage Environment Temperature16 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method
Radiation Sterilization

Contacts

PhoneEmail
+1(845)610-5587fma@rmsmedpro.com

Regulatory Flags

DUNS number
048403299
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
true

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