NA

Basic Information

• Brand Name: NA
• Primary DI: 07332414075828
• Version / Model: 6033765
• Catalog Number: 107650
• Company Name: GAMBRO DASCO SPA
• Labeler DUNS: 428788780
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-07-30
• Public Version: 5
• Public Version Date: 2023-07-19
• Public Version Status: Update
• Public Device Record Key: c28c6df6-bb6c-4928-ab9b-aff64e2385dd

Device Description

SP 418 (9L Bag) Accessory Drain Bag

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
MON	SYSTEM, HEMODIALYSIS, REMOTE ACCESSORIES	Gastroenterology, Urology	876.5820	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58848	Extracorporeal circuit waste bag	A flexible container intended to be used for the collection of waste fluids during preparation and processing of an extracorporeal circuit (e.g., autotransfusion, haemodialysis, haemofiltration, apheresis, adsorption treatment), including the collection and rinsing of ultrafiltrate fluid which may contain blood components. The device typically consists of a plastic pouch with a piece of short tubing and a connector (e.g., Luer-lock) intended to be connected to the tubing system of the extracorporeal circuit and possibly an outlet tap. The contents are considered potentially contaminated and should be disposed of according to local requirements. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	37332414075829	GS1	CASE	30	In Commercial Distribution
Primary	07332414075828	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	9	Liter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – 30 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Minimum temperature of use 20 degree Celsius