FDA UDI
In Commercial Distribution
🇺🇸 United States
mcompass Anorectal Manometry System
DI: 00851607003396
·
Model: RMD-001U
·
MEDSPIRA, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- mcompass Anorectal Manometry System
- Primary DI
- 00851607003396
- Version / Model
- RMD-001U
- 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
- bfd9af03-f46c-4054-a9af-df64fc622316
Device Description
mcompass Anorectal Manometry System
Device Characteristics
- Single Use
- No
- 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
- No
- 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 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Package | 10851607003393 | GS1 | Shipper | 1 | In Commercial Distribution | |
| Primary | 00851607003396 | GS1 |
Customer Contacts
- Phone
- 612-789-0013
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K143031 | 000 |