Pall® Total Nutrient Admixture Filter

Basic Information

• Brand Name: Pall® Total Nutrient Admixture Filter
• Primary DI: 00636207000699
• Version / Model: TNA1
• Catalog Number: TNA1
• Company Name: Global Life Sciences Solutions USA LLC
• Labeler DUNS: 011658242
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-06-01
• Public Version: 4
• Public Version Date: 2024-02-29
• Public Version Status: Update
• Public Device Record Key: 4ccd657c-45b2-43e2-ab86-7d448b6cf603

Device Description

1.2 micron Total Nutrient Admixture Filter with Non-Phthalate Fluid Pathway

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• 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: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FPB	Filter, infusion line	General Hospital	880.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35072	Intravenous line filter	A sterile device designed to remove microorganisms and particulate matter from solutions in an infusion/intravenous (IV) line; it can also be used to remove air. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30636207000690	GS1	case	40	In Commercial Distribution
Primary	00636207000699	GS1

Customer Contacts

• Phone: [phone] ext. 5164843600
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K905794	000

Device Sizes

Type	Value	Unit	Text
Pore Size	1.2	Micrometer