Curve

Basic Information

• Brand Name: Curve
• Primary DI: 10885403241208
• Version / Model: 42-2070
• Catalog Number: 42-2070
• Company Name: CAREFUSION 2200, INC
• Labeler DUNS: 832696038
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-03-16
• Public Version: 5
• Public Version Date: 2023-08-01
• Public Version Status: Update
• Public Device Record Key: 973bc440-c76c-4c0c-ac09-06166b8a6bd3

Device Description

Curve Ascites Shunt PAK, Ascites Shunt Percutaneous Access Kit / Double-Valved - 11.5 Fr

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: No
• MRI Safety: MR Safe
• 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
DYB	INTRODUCER, CATHETER	Cardiovascular	870.1340	2
KPM	SHUNT, PERITONEAL	Gastroenterology, Urology	876.5955	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60437	Interventional radiology percutaneous-access kit, single-use	A collection of various instruments/devices (e.g., introducer sheath, dilator, guides, cannula, needle, angiographic catheter) intended to be used for percutaneous body-access to facilitate a radiological image-guided interventional radiology or surgical procedure [e.g., bile duct biopsy, percutaneous transhepatic cholangiogram, non-vascular drainage procedures, ultrasound-guided spinal surgery]. Some types are designed to function as a channel to facilitate the introduction of radiological image guidance devices (e.g., ultrasound probe/transducer) [not included]. It does not contain pharmaceuticals. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50885403241206	GS1	Case	5	In Commercial Distribution
Primary	10885403241208	GS1

Customer Contacts

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