Leak Pnt Det, Single

Basic Information

• Brand Name: Leak Pnt Det, Single
• Primary DI: 00890477000289
• Version / Model: LPD-3D
• Company Name: SRS Medical Systems, Inc.
• Labeler DUNS: 796263598
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-12-24
• Public Version: 1
• Public Version Date: 2019-01-24
• Public Version Status: New
• Public Device Record Key: 868573bb-69de-4845-871e-cb8dcadcfdd0

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: 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
EXQ	Cystometer, Electrical Recording	Gastroenterology, Urology	876.1620	2

GMDN Terms

Code	Name	Definition	Implantable	Status
11111	Cystometer	A device used to examine the bladder, providing measurement data concerning pressure and volume. This data will be used for diagnostic evaluation of the neuromuscular mechanisms of the bladder. It may also measure the amount of residual urine after the patient has passed water. The device may operate mechanically, by ultrasound techniques, or a combination of both. For more advanced diagnosis/study of the bladder see the appropriate GMDN code.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00890477000241	GS1		10	In Commercial Distribution
Primary	00890477000289	GS1