FDA UDI
In Commercial Distribution
🇺🇸 United States
Diversatek Healthcare
DI: 00816734023433
·
Model: MANO-KIT
·
DIVERSATEK HEALTHCARE, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Diversatek Healthcare
- Primary DI
- 00816734023433
- Version / Model
- MANO-KIT
- Catalog Number
- MANO-KIT
- Company Name
- DIVERSATEK HEALTHCARE, INC.
- Labeler DUNS
- 030650113
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-05-16
- Public Version
- 2
- Public Version Date
- 2025-11-24
- Public Version Status
- Update
- Public Device Record Key
- 9bcad58c-d6e7-4587-80d2-f796ad4fd4dc
Device Description
Manometry Starter Kit
Device Characteristics
- Single Use
- No
- 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
- No
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| FFX | System, Gastrointestinal Motility (Electrical) | 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 |
|---|---|---|---|---|---|---|
| Primary | 00816734023433 | GS1 |
Customer Contacts
- Phone
- 800-558-6408
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K012232 | 000 |