ButtonHole with SteriPick TWINPACK+ NEEDLE SET

Basic Information

• Brand Name: ButtonHole with SteriPick TWINPACK+ NEEDLE SET
• Primary DI: 00842289101982
• Version / Model: BH-2005PE
• Company Name: NXSTAGE MEDICAL, INC.
• Labeler DUNS: 088013219
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-06-24
• Public Version: 1
• Public Version Date: 2020-07-02
• Public Version Status: New
• Public Device Record Key: 2a2e12eb-2612-486a-9134-21439f1da3bf

Device Description

TWINPACK BUTTONHOLE FISTULA NEEDLE SET 15G X 1" W/ STERIPICK TOTAL CASE QTY 250 (115 TWIN POUCHES + 20 SINGLE POUCHES)

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
FIE	Needle, Fistula	Gastroenterology, Urology	876.5540	2

GMDN Terms

Code	Name	Definition	Implantable	Status
12741	Haemodialysis needle	A sterile, sharp bevel-edged, hollow tubular metal instrument used to remove and return a patient's blood during a haemodialysis procedure. Commonly known as a dialysis needle. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00842289101982	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Needle Gauge	15	Gauge
Length	1	Inch

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – 40 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry