FDA UDI
Not in Commercial Distribution
🇺🇸 United States
ManoScan
DI: 07290101363347
·
Model: 800002
·
Given Imaging, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ManoScan
- Primary DI
- 07290101363347
- Version / Model
- 800002
- Company Name
- Given Imaging, Inc.
- Labeler DUNS
- 090073722
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 13
- Public Version Date
- 2023-12-06
- Public Version Status
- Update
- Public Device Record Key
- 609a3fd5-e571-440a-94eb-9f3f6a79eb6b
- Distribution End Date
- 2016-09-24
Device Description
A510 Module
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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 | 07290101363347 | GS1 |
Customer Contacts
- Phone
- +1(508)261-8000
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry;Fragile
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 100 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 70 Degrees Celsius
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- .5 – 1.06 KiloPascal