Tandem Diabetes 5mL LL WITH CO-PACKED NEEDLE 26Gx3/8’’

Basic Information

• Brand Name: Tandem Diabetes 5mL LL WITH CO-PACKED NEEDLE 26Gx3/8’’
• Primary DI: 00020221012163
• Version / Model: 1001216
• Catalog Number: 1001216
• Company Name: Exel International
• Labeler DUNS: 180572216
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-04-17
• Public Version: 1
• Public Version Date: 2023-04-25
• Public Version Status: New
• Public Device Record Key: 22f83003-25d5-45f7-84e6-bf5de1adae32

Device Description

Tandem Diabetes 5mL LL WITH CO-PACKED NEEDLE 26Gx3/8’’ 100/BX, 800/CS

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FMF	Syringe, Piston	General Hospital	880.5860	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63095	General-purpose syringe/needle	A sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a non-retractable needle is included, either attached or detached (usually capped for user protection). It is intended for various medical applications and is not dedicated to medication administration. The syringe is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10020221012160	GS1	Inner box	100	In Commercial Distribution
Primary	00020221012163	GS1
Package	20020221012167	GS1	Case	800	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K861153	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 25 Degrees Celsius