FDA UDI
Not in Commercial Distribution
🇺🇸 United States
NA
DI: 00816765013168
·
Model: 710603
·
US Endoscopy
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 00816765013168
- Version / Model
- 710603
- Catalog Number
- 710603
- Company Name
- US Endoscopy
- Labeler DUNS
- 627879687
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-17
- Public Version
- 5
- Public Version Date
- 2022-07-04
- Public Version Status
- Update
- Public Device Record Key
- 301ae9ae-bad8-434e-9dea-ced4ab6758f4
- Distribution End Date
- 2020-03-31
Device Description
The High Pressure Hose and Yoke for CO2 for use with US Endoscopy CO2 Insufflators in conjunction with medical grade CO2 cylinders with standard yoke connectors.
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
- Yes
- 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 |
|---|---|---|---|---|
| FCX | INSUFFLATOR, AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 14239 | High-pressure medical gas hose | A length of flexible tube intended to deliver and withstand gases under very high pressure, e.g., greater than 200 bar/3000 pounds per square inch (psi). It may be composed of any of several malleable or semi-rigid materials (e.g., plastic, rubber, or nylon), and braided with cotton wool and/or stainless steel. It is typically used to transport high pressure compressed medical gas to a pressure regulating device. It is available in various lengths, including standard coil lengths. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816765013168 | GS1 |
Customer Contacts
- Phone
- +1(800)548-4873
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K111648 | 000 |