NA

Basic Information

• Brand Name: NA
• Primary DI: 07332414075439
• Version / Model: 6033112
• Catalog Number: 107620
• Company Name: GAMBRO DASCO SPA
• Labeler DUNS: 428788780
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-05-31
• Public Version: 8
• Public Version Date: 2023-07-27
• Public Version Status: Update
• Public Device Record Key: b5ab3be8-4192-4579-8baf-2e38506a56e3

Device Description

SP-420 Accessory extension line

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: 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
KOC	ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS	Gastroenterology, Urology	876.5820	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34999	Haemodialysis blood tubing set, single-use	A collection of tubing segments and associated devices (e.g., connectors, clamps) intended to be used to transfer blood between a patient's vascular access device and a haemodialyser during haemodialysis; it is sometimes referred to as haemodialysis blood lines. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	37332414075430	GS1	CASE	36	In Commercial Distribution
Primary	07332414075439	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – 30 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 32 – 86 Degrees Fahrenheit
• Type: Special Storage Condition, Specify
• Special Conditions: Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit, Keep dry