Monoject

Basic Information

• Brand Name: Monoject
• Primary DI: 10884527002863
• Version / Model: 8881301116
• Catalog Number: 8881301116
• Company Name: Cardinal Health, Inc.
• Labeler DUNS: 080935429
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 8
• Public Version Date: 2022-05-31
• Public Version Status: Update
• Public Device Record Key: 909bc80b-8edc-4103-ad40-6fd1340aea2b
• Distribution End Date: 2022-05-31

Device Description

Blood Collection Tube,Silicone Coated Tube, Glycerine Coated Red Stopper, No Additive, 2 mL Draw

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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GIM	Tubes, vacuum sample, with anticoagulant	Clinical Chemistry	862.1675	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37563	Non-evacuated blood collection tube IVD, no additive	A non-evacuated glass or plastic tube, sealed with a stopper, containing no additive and intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20884527002860	GS1	CASE	1000	Not in Commercial Distribution	2022-05-31
Primary	10884527002863	GS1
Unit of Use	30884527002867	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	50	Millimeter
Total Volume	2	Milliliter
Outer Diameter	10.25	Millimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry; Fragile;AVOID DIRECT SUNLIGHT