SEDASYS

Basic Information

• Brand Name: SEDASYS
• Primary DI: 10705036003434
• Version / Model: SEDCAS01
• Catalog Number: SEDCAS01
• Company Name: ETHICON ENDO-SURGERY, INC.
• Labeler DUNS: 123407392
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-17
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 534ed14f-7591-4dab-ae2e-9b69e62d73b8
• Distribution End Date: 2017-08-09

Device Description

SEDASYS DRUG DELIVERY CASSETTE

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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PDR	Computer-assisted personalized sedation system	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
55791	Rifabutin IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of rifabutin in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20705036003431	GS1	BOX	20	Not in Commercial Distribution	2017-08-09
Primary	10705036003434	GS1