Micro pipette, plastic EDTA

Basic Information

• Brand Name: Micro pipette, plastic EDTA
• Primary DI: 07350040790687
• Version / Model: Micro pipette, plastic EDTA 1x100
• Catalog Number: 1070039
• Company Name: Boule Medical AB
• Labeler DUNS: 354417933
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-10-04
• Public Version: 1
• Public Version Date: 2024-10-14
• Public Version Status: New
• Public Device Record Key: 3cf68b45-5c5f-4e2d-9bde-fdb6f3593d43

Device Description

Accessory for the MPA use in Medonic M-series, Swelab Alfa-series, and Boule 950-series hematology analyzer for blood collection from a finger stick or a venous blood sample and direct insertion into the Micro Pipette Adapter (MPA) inlet of Medonic M-series, Swelab Alfa-series, and Boule 950-series automated hematology analyzers.

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: Yes
• 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
GIO	Tube, Collection, Capillary Blood	Hematology	864.6150	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58154	Capillary blood transfer tube IVD, EDTA	A non-sterile glass or plastic capillary blood transfer tube coated internally with the anticoagulant ethylenediaminetetraacetic acid (EDTA), and intended to be attached to a non-evacuated blood collection tube to assist with the transfer of blood drops from the blood collection site into the collection tube using a capillary action. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	07350040790250	GS1		10	In Commercial Distribution
Primary	07350040790687	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 30 Degrees Celsius