Endure

Basic Information

• Brand Name: Endure
• Primary DI: 00840118604093
• Version / Model: SB213A4-0520
• Catalog Number: SB213A4
• Company Name: ENDURE INDUSTRIES
• Labeler DUNS: 066087031
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-29
• Public Version: 1
• Public Version Date: 2020-10-07
• Public Version Status: New
• Public Device Record Key: b6123289-88b0-41ec-b7ff-472e676eec3e

Device Description

Safety Blood Collection Set, 21G, 3/4", Sterile

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: 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
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	862.1675	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58490	Venous butterfly needle/set	An invasive, hollow, tubular, metal device intended to puncture a vein to collect blood and/or for transient (<24 hours) or short-term (<= 30 days) administration of intravenous (IV) fluids. It includes wings for fixation/placement and may include tubing and/or connectors; however, it does not include accessories to facilitate introduction (e.g., stylet). The device may also be referred to as butterfly needle or scalp vein needle. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00840118604109	GS1	Box	100	In Commercial Distribution
Primary	00840118604093	GS1
Package	00840118604116	GS1	Case	20	In Commercial Distribution

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Needle Gauge	21	Gauge
Catheter Length	.75	Inch

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – 49 Degrees Celsius