FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 10845854080122
·
Model: C7011
·
Conmed Corporation
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
10
Basic Information
- Brand Name
- NA
- Primary DI
- 10845854080122
- Version / Model
- C7011
- Catalog Number
- C7011
- Company Name
- Conmed Corporation
- Labeler DUNS
- 071595540
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2020-09-24
- Public Version
- 1
- Public Version Date
- 2020-10-02
- Public Version Status
- New
- Public Device Record Key
- 99e7c8a5-afaa-4934-90b9-185b6decb2ab
Device Description
TUBING SET, WITH FILTER FOR LAPAROFLATOR, QTY 10
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
- Yes
- 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 |
|---|---|---|---|---|
| NKC | Tubing/tubing with filter, insufflation, laparoscopic | Obstetrics/Gynecology | 884.1730 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38559 | Insufflation gas conditioning tubing set | A collection of sterile and non-sterile devices intended to be used with an insufflation gas conditioning system and/or a laparoscopic gas distention system, or other gas source, to condition the insufflation gas stream [typically carbon dioxide (CO2)] by heating and humidifying it before introduction into the peritoneal cavity or a wound during laparoscopic or open surgery. It is available in various configurations but typically includes a connection tube for connection to the gas source, an electrically-heated tube for transport of the conditioned gas to the operative site, a humidification chamber, a gas filter, and connectors. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20845854080129 | GS1 | BOX | 10 | In Commercial Distribution | |
| Primary | 10845854080122 | GS1 | ||||
| Unit of Use | 00845854080125 | GS1 |
Customer Contacts
- Phone
- +1(800)237-0169
- [email protected]