PettyPip

Basic Information

• Brand Name: PettyPip
• Primary DI: 08809408863505
• Version / Model: PettyPip
• Catalog Number: CT10300E
• Company Name: Sugentech Inc._Osong Branch
• Labeler DUNS: 694860936
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2025-05-15
• Public Version: 1
• Public Version Date: 2025-05-23
• Public Version Status: New
• Public Device Record Key: 6d98ad19-7760-47ac-bf56-a333103a2089

Device Description

The pettyPip is a device for collecting 10 uL of whole blood and injecting it into the IVD device, such as POC or NPT devices. This device is composed of two parts; a Tip and a Plunger. The hole at the top end of the plunger provides sample collection through capillary action.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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
GIO	Tube, Collection, Capillary Blood	Hematology	864.6150	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65289	Biological fluid specimen capillary collector IVD	A sampling receptacle in the form of small plastic tube with a thin pointed tip intended to be used to collect any type of biological fluid specimen (e.g., tears, saliva, sweat, urine) from a patient’s body via capillary action. It is designed to be placed on the target fluid whereby the fluid is drawn into the vessel for its collection, containment, preservation and/or transportation for subsequent culture, 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
Primary	08809408863505	GS1
Unit of Use	08809408863512	GS1

Customer Contacts

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

Storage Conditions

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