FDA UDI
Not in Commercial Distribution
🇺🇸 United States
IRRIGATOR/INSUFFLATOR
DI: 04961333241729
·
Model: 100130P
·
PENTAX OF AMERICA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- IRRIGATOR/INSUFFLATOR
- Primary DI
- 04961333241729
- Version / Model
- 100130P
- Company Name
- PENTAX OF AMERICA, INC.
- Labeler DUNS
- 083211284
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2018-03-13
- Public Version
- 3
- Public Version Date
- 2018-10-08
- Public Version Status
- Update
- Public Device Record Key
- db3a1ee3-aa54-478d-b432-ad572aadc5b6
- Distribution End Date
- 2018-06-21
Device Description
IRRIG TUBING, EGA-500P, 10/PKG
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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FEQ | Pump, Air, Non-Manual, For Endoscope | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47800 | Surgical fluid/gas irrigator | A sterile, hand-operated surgical device intended for the controlled delivery of medical gas and fluid (e.g., saline solution) to an open surgical site to improve visibility, by clearing bloody fluids/debris, and to prevent tissue desiccation. It is typically made of plastic materials [e.g., polypropylene, polyvinyl chloride (PVC)] and may be double-lumen for nebulization of fluid/gas, or dual-line for separate fluid and gas administration and include an antibacterial filter. It typically includes a nozzle at the distal end and connector(s) [e.g., Luer] at the proximal end for connection to the fluid/gas sources; a manual tubing clamp may also be included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04961333241729 | GS1 | ||||
| Unit of Use | 14961333241726 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K092429 | 000 |