FDA UDI
In Commercial Distribution
🇺🇸 United States
NAJA
DI: 00191506060985
·
Model: 9A-03110
·
Médical Chess Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- NAJA
- Primary DI
- 00191506060985
- Version / Model
- 9A-03110
- Catalog Number
- 9A-03110
- Company Name
- Médical Chess Inc
- Labeler DUNS
- 243279393
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-05-23
- Public Version
- 1
- Public Version Date
- 2025-06-02
- Public Version Status
- New
- Public Device Record Key
- a160d5bc-103f-4b4e-83e7-90ff33fa6cdd
Device Description
Gastrointestinal Balloon Catheter
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FGD | CATHETER, RETENTION, BARIUM ENEMA WITH BAG | Gastroenterology, Urology | 876.5980 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 67509 | Enteroclysis balloon catheter | A long, thin, flexible tube with one or more inflatable balloons at its distal tip designed to be introduced through the working channel of a gastroscope to access the small intestines (duodenum or jejunum) to administer fluids used for enteroclysis procedures (e.g., contrast medium), for radiographic visualization of the area. The balloon is inflated to its prescribed diameter to temporarily occlude the lumen of the small intestine to facilitate fluid infusion. It features a multichannel port at the proximal end for guidewire insertion, fluid infusion and individual balloon inflation. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00191506060985 | GS1 |