N/A

Basic Information

• Brand Name: N/A
• Primary DI: 04052536179923
• Version / Model: XD 2037
• Catalog Number: XD 2037
• Company Name: Ulrich GmbH & Co. KG
• Labeler DUNS: 315494757
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-03-12
• Public Version: 2
• Public Version Date: 2022-06-08
• Public Version Status: Update
• Public Device Record Key: c0901822-7e1d-42ab-b2ab-3a16548a6b5b

Device Description

Patient tubing 150 cm for Pump tubing - flex

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IZQ	Injector, contrast medium, automatic	Cardiovascular	870.1650	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35833	Electric infusion pump administration set, single-use	A collection of sterile devices (e.g., plastic tubing, check valve, roller clamp, Y-site connector, Luer, needle/catheter) intended to be used in combination with an electrically-powered infusion pump for the intravenous (IV), subcutaneous, intramuscular, or epidural administration of medication. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04052536179923	GS1
Package	04052536179930	GS1		100	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K171392	000
K192872	000
K210541	000