Parker Labs

Basic Information

• Brand Name: Parker Labs
• Primary DI: 00855683006142
• Version / Model: Transeptic Cleansing Solution
• Catalog Number: 09-25
• Company Name: PARKER LABORATORIES INC
• Labeler DUNS: 002449593
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-19
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 068bf6f9-ab09-4666-b05b-2fcb30784ea7
• Distribution End Date: 2017-01-18

Device Description

Transeptic Cleansing Solution, 250mL bottle

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
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	892.1560	2

GMDN Terms

Code	Name	Definition	Implantable	Status
59059	Wash/cleaning solution IVD, manual equipment	A wash or cleaning solution intended to be used in the preparation, decontamination and/or cleanup of equipment (e.g., glassware, weighing equipment) used for the manual processing, staining and/or testing of clinical laboratory specimens.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00855683006142	GS1

Customer Contacts

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