Single Patient Kit, mcompass, Anorectal Manometry 5-channel, Petite

Basic Information

• Brand Name: Single Patient Kit, mcompass, Anorectal Manometry 5-channel, Petite
• Primary DI: 00851607003334
• Version / Model: RMD-002-010
• Company Name: MEDSPIRA, LLC
• Labeler DUNS: 962187964
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-10-06
• Public Version: 1
• Public Version Date: 2023-10-16
• Public Version Status: New
• Public Device Record Key: 3cb05198-f8f7-4a19-9610-995d41ec3891

Device Description

Single Patient Kit, mcompass, Anorectal Manometry 5-channel, Petite

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KLA	Monitor, Esophageal Motility, Anorectal Motility, And Tube	Gastroenterology, Urology	876.1725	2
HCC	Device, Biofeedback	Neurology	882.5050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17781	Rectosphincteric balloon	A hollow rubber structure, expandable with either liquid or air, used in conjunction with a manometer to assess anorectal function (anorectal manometry), typically to evaluate the rectosphincteric reflex upon balloon dilation. The device is typically used in the investigation of lower bowel disorders such as faecal incontinence or Hirschsprung's disease (HD). This is a single-use device.	No	Active
35053	Manometric gastrointestinal motility analysis system	An assembly of devices which includes a main computerized unit designed to evaluate peristaltic motility in the gastrointestinal tract by measuring pressure using an intraluminal sensor catheter/probe at several points; it may also measure pH, respiration, and swallowing with appropriate sensors. In addition to the central computer with software it may includethe appropriate perfusion and/or nonperfusion catheters. It is intended to evaluate patients with dysphagia, gastro-oesophageal reflux disease (GERD), noncardiac chest pain, and/or assess connective tissue and neuromuscular disease.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00851607003334	GS1
Package	10851607003331	GS1	Shipper	1	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K143031	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Product should be kept dry
• Type: Handling Environment Temperature
• Temperature Range: 2 – 25 Degrees Celsius