Silicone Reservoir Bag 3L (600 040 003GE)

Basic Information

• Brand Name: Silicone Reservoir Bag 3L (600 040 003GE)
• Primary DI: 05055788777373
• Version / Model: 2106570-028
• Company Name: FLEXICARE MEDICAL LIMITED
• Labeler DUNS: 504406273
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-06-17
• Public Version: 1
• Public Version Date: 2020-06-25
• Public Version Status: New
• Public Device Record Key: e2b5d820-6555-464e-9147-f1289b6b622f

Device Description

Silicone Reservoir Bag 3L (600 040 003GE)

Device Characteristics

• Single Use: No
• 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
BTC	Bag, Reservoir	Anesthesiology	868.5320	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37709	Breathing circuit bag, reusable	A non-sterile elastomeric reservoir sac intended to store breathing gas during the respiratory cycle. The breathing bag may be on the inspiratory or expiratory limb of a breathing circuit depending on the breathing circuit design. It may also function as a maximum pressure limiting device during spontaneous or manually assisted ventilation. It may be made of conductive or non-conductive material and is typically used in anaesthesia or ventilator breathing circuits. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05055788777373	GS1