RMS Precision Flow Rate TubingTM

Basic Information

• Brand Name: RMS Precision Flow Rate TubingTM
• Primary DI: 00659443000100
• Version / Model: F15
• Catalog Number: F15
• Company Name: REPRO MED SYSTEMS, INC.
• Labeler DUNS: 048403299
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-19
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 3d62f954-cd8d-4aaa-bee8-6925bba22cf5

Device Description

Flow Control Infusion Tubing

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Radiation Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FRN	Pump, infusion	General Hospital	880.5725	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46846	Mechanical infusion pump administration set	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10659443000107	GS1	Carton	50	In Commercial Distribution
Primary	00659443000100	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K933652	000

Device Sizes

Type	Value	Unit	Text
Lumen/Inner Diameter	0.0084	Inch

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store at room temperature
• Type: Storage Environment Temperature
• Temperature Range: 16 – 30 Degrees Celsius