i-STAT

Basic Information

• Brand Name: i-STAT
• Primary DI: 00054749004027
• Version / Model: 06F24-20
• Catalog Number: 06F24-20
• Company Name: ABBOTT POINT OF CARE INC.
• Labeler DUNS: 079226216
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2023-09-22
• Public Version: 1
• Public Version Date: 2023-10-02
• Public Version Status: New
• Public Device Record Key: 5dfd0066-714b-4376-9207-5ca2e105d473

Device Description

Dispensing Tip, 100 Pack

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JRC	Micro Pipette	Clinical Chemistry	862.2050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58146	Blood/blood culture specimen transfer spike IVD	A blood or blood culture specimen transfer device intended to be used to obtain for analysis a specimen of blood, blood components (e.g., platelets), or blood culture from a specimen receptacle, and facilitate specimen transfer to another receptacle [e.g., evacuated blood collection tube]. It is a hand-held, manually-operated device with a spike/needle for sampling the specimen through the sealed stopper of the receptacle (i.e., without opening the receptacle), and is designed to reduce the risk of user exposure to the specimen and spike/needle [e.g., has a plastic housing for guarding the needle]. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	10054749004024	GS1
Primary	00054749004027	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius