H-Pette II (No Blade, Metal Canula) (1000 pieces)

Basic Information

• Brand Name: H-Pette II (No Blade, Metal Canula) (1000 pieces)
• Primary DI: M52536150
• Version / Model: 3615
• Company Name: HELENA LABORATORIES CORPORATION
• Labeler DUNS: 079396131
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-05-26
• Public Version: 6
• Public Version Date: 2025-06-09
• Public Version Status: Update
• Public Device Record Key: 282bf1e9-d068-4368-aff2-d46fa271acc3

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GJG	Pipette, Quantitative, Hematology	Hematology	864.6160	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58146	Blood/blood culture specimen transfer spike IVD, manual	A hand-held manual device intended to be used to obtain a specimen of blood, blood components (e.g., platelets), or blood culture from a specimen receptacle, and facilitate its transfer to another receptacle [e.g., evacuated blood collection tube] for subsequent analysis. It consists of 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
Primary	M52536150	HIBCC

Customer Contacts

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