PICO70

Basic Information

• Brand Name: PICO70
• Primary DI: 05700699565198
• Version / Model: 956-519
• Catalog Number: 956-519
• Company Name: Radiometer Medical ApS
• Labeler DUNS: 308667539
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2016-09-01
• Public Version: 3
• Public Version Date: 2022-09-16
• Public Version Status: Update
• Public Device Record Key: 29be0adc-4525-4fc5-a322-5d9dbfd5d39c
• Distribution End Date: 2021-09-24

Device Description

PICO70 Arterial blood sampler w/o needle, 1.5 mL, box of 100 units

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
JKA	Tubes, vials, systems, serum separators, blood collection	Clinical Chemistry	862.1675	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45267	Blood gas syringe IVD, sodium heparin	A sterile glass or plastic syringe, without a pre-attached needle, containing the anticoagulant sodium heparin intended to be used for the collection, and preservation and/or transport, of blood for blood gas determination and/or other investigation. This is a single-use device.	No	Active
57894	Blood gas syringe IVD, lithium heparin	A sterile glass or plastic syringe, without a pre-attached needle, containing the anticoagulant lithium heparin intended to be used for the collection, and preservation and/or transport, of blood for blood gas determination 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
Primary	05700699565198	GS1
Unit of Use	55700699565193	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 32 Degrees Celsius