Deltec

Basic Information

• Brand Name: Deltec
• Primary DI: 10610586013225
• Version / Model: 21-0501-01
• Company Name: SMITHS MEDICAL MD, INC.
• Labeler DUNS: 106712748
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-21
• Public Version: 4
• Public Version Date: 2018-08-17
• Public Version Status: Update
• Public Device Record Key: 3c470f88-b93b-4008-9d86-c25a03a6c8a4

Device Description

PAC SYS, EPIDURAL, SS, PU, 1.2 MM, /CS 1/EA

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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
LNY	Catheter, Percutaneous, Long Term, Intraspinal	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
33923	Infusion/injection port/catheter, implantable	A sterile short- or long-term implantable device composed of a metal or plastic portal with septum, connected to a catheter, intended to be used for the delivery of drugs or other fluids to various anatomical regions or vessels. The device is implanted subcutaneously (under the skin), and delivery of drugs and fluids can be accomplished using a medical (drug/fluid) delivery pump or bolus injection. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10610586013225	GS1

Premarket Submissions

Submission Number	Supplement Number
P900052	018