SPIKE ADAPTER

Basic Information

• Brand Name: SPIKE ADAPTER
• Primary DI: 04046964183454
• Version / Model: 418121
• Catalog Number: 418121
• Company Name: B. BRAUN MEDICAL INC.
• Labeler DUNS: 002397347
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 6
• Public Version Date: 2020-11-06
• Public Version Status: Update
• Public Device Record Key: 7291dc9c-1f1b-4bad-b94c-f1969f833938

Device Description

PINNACLE® Vented Micro Spike Adapter

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: 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FPA	Set, administration, intravascular	General Hospital	880.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64997	Non-ISO80369 formatted bag access spike	A small, noninvasive, tubular connector with a small-bore connection/port, none of which is designed according to ISO 80369 (non-ISO80369 formatted), and a hollow bag-access spike (either blunt or sharp) intended to connect an intravenous (IV) fluid or blood bag to a fluid line for administration to a patient. It may include a built-in air filter and drip chamber; it does not include tubing (i.e., not a tubing set) or any Luer formatted connections. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04046964183454	GS1
Unit of Use	04046964183447	GS1

Customer Contacts

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