Atlanta Healthcare Services OcuDrape®

Basic Information

• Brand Name: Atlanta Healthcare Services OcuDrape®
• Primary DI: 10852171007589
• Version / Model: 10852171007589
• Catalog Number: AHS340NS
• Company Name: ATLANTA HEALTHCARE SERVICES, INC.
• Labeler DUNS: 130599421
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2018-11-09
• Public Version: 1
• Public Version Date: 2018-12-10
• Public Version Status: New
• Public Device Record Key: 390ea96e-baa0-452a-86cc-dbe651796fd6

Device Description

Fluid Pouch 80cc with Eye Wick/Drain, Clear Plastic 2 x 9 in. (5 x 23 cm.)

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: 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HMT	Drape, Patient, Ophthalmic	General, Plastic Surgery	878.4370	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58982	Surgical tissue/fluid collection bag, non-sterile	A non-sterile flexible container (a pouch) designed to be attached adjacent to a site of surgical intervention to collect and store body fluids, tissue, or body parts (e.g., a limb) released during the procedure. It is typically constructed as a pouch made of plastic foils with an adhesive band for attachment (e.g., next to the patient's skin incision or on the sterile drape), is available in a variety of sizes, and may be equipped with a fluid filter. This device is not intended to connect to an active drainage system or suction system but relies on gravity for fluid collection. This is a single-use device intended to be sterilized prior to use.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10852171007589	GS1
Unit of Use	00852171007582	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K854613	000

Device Sizes

Type	Value	Unit	Text
Length	9	Inch
Width	2	Inch