Patient Controlled Intravenous Analgesia Device (PCI)

Basic Information

• Brand Name: Patient Controlled Intravenous Analgesia Device (PCI)
• Primary DI: 09350902000280
• Version / Model: PCI Tamper Evident
• Catalog Number: PCIIVRE5TE
• Company Name: GO MEDICAL INDUSTRIES PTY. LTD.
• Labeler DUNS: 757634266
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-05-18
• Public Version: 4
• Public Version Date: 2022-06-17
• Public Version Status: Update
• Public Device Record Key: eb84ad57-5a63-4882-9c61-c3f446087565

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MEB	Pump, Infusion, Elastomeric	General Hospital	880.5725	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61732	Ambulatory non-insulin infusion pump, mechanical, single-use	A portable, non-electric, mechanically-powered device designed to be operated by healthcare professionals for dispensing a single dose of fluid medication [e.g., for antibiotic therapy, chemotherapy, patient-controlled analgesia (PCA)]. It consists of an empty reservoir intended to be filled with medication, a flow-rate regulator and a non-sterile (sterilizable) administration line intended to be connected to an infusion catheter (not included) for intravenous (IV), subcutaneous, intramuscular, or epidural administration. It may include flow and fluid level mechanical indicators and may be worn by the patient within and outside healthcare settings. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	09350902000303	GS1	Shipping carton	60	In Commercial Distribution
Primary	09350902000280	GS1
Package	09350902000297	GS1	Carton	10	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K972158	000