BD SmartSite Bag 500mL

Basic Information

• Brand Name: BD SmartSite Bag 500mL
• Primary DI: 00382902005001
• Version / Model: 11365-325-04
• Catalog Number: 200500
• Company Name: Gilero, LLC
• Labeler DUNS: 158233937
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-12-01
• Public Version: 1
• Public Version Date: 2023-12-11
• Public Version Status: New
• Public Device Record Key: da43c278-61b4-4c7c-9b30-6086b3a5df29

Device Description

The SmartSite Bag is an empty container used for administration of intravenous solutions to the patient using an intravascular administration set. Medication transfer in and out of the container is done using aseptic technique.

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: No
• 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KPE	Container, I.V.	General Hospital	880.5025	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35127	Intravenous administration bag/bottle	An empty pouch or bottle made of plastic or glass intended to contain a fluid (e.g., saline, medication) for intravenous (IV) administration; some types may in addition be intended for enteral feeding applications. It may be composed of one or more chambers and might be provided with a short length of tubing; however, it does not include other associated items (e.g., clamp, spike) [i.e., not an IV administration set] and is not intended to be directly connected to the IV catheter. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50382902005006	GS1	Shipper	125	In Commercial Distribution
Primary	00382902005001	GS1

Device Sizes

Type	Value	Unit	Text
Total Volume	500	Milliliter