Pall® CellWash/Infusion Bag Set

Basic Information

• Brand Name: Pall® CellWash/Infusion Bag Set
• Primary DI: 00636207302434
• Version / Model: 791-03
• Catalog Number: 791-03
• 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: 659e70d2-018a-4fb0-9932-5fcdb1e0db57

Device Description

Two empty transfer bags with two spikes and luer adapter and associated tubing for washing blood and cellular components.

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: Radiation Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KSR	CONTAINER, EMPTY, FOR COLLECTION & PROCESSING OF BLOOD & BLOOD COMPONENTS	Hematology	864.9100	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47115	Umbilical cord blood collection set	A group of devices intended to be used to collect, process, and store umbilical cord blood and/or umbilical cord blood components (e.g., buffy coat). It typically includes tubing, hollow needles for insertion into the umbilical cord (a double venipuncture of the cord) to collect the blood, and several containers (flexible bags usually containing an anticoagulant) intended for transitional (room temperature) or long-term (frozen) blood storage. The cord blood is usually intended to be frozen and stored, typically to preserve stem cells, for subsequent reinfusion into patients, generally in cases of leukaemia. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30636207302435	GS1	case	24	In Commercial Distribution
Primary	00636207302434	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	250	Milliliter
Device Size Text, specify			maximum 250 mL fill volume per bag