FDA UDI
In Commercial Distribution
🇺🇸 United States
SMITH & NEPHEW 400
DI: 00885554011203
·
Model: 7209939
·
Smith & Nephew, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SMITH & NEPHEW 400
- Primary DI
- 00885554011203
- Version / Model
- 7209939
- Catalog Number
- 7209939
- Company Name
- Smith & Nephew, Inc.
- Labeler DUNS
- 045483575
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-08-30
- Public Version
- 5
- Public Version Date
- 2023-09-07
- Public Version Status
- Update
- Public Device Record Key
- b298c460-46ef-4e0e-a686-aa0280d94e4b
Device Description
S&N 400 INSUFFLATOR KIT SPANISH
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
- 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 |
|---|---|---|---|---|
| HIF | INSUFFLATOR, LAPAROSCOPIC | Obstetrics/Gynecology | 884.1730 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48169 | Insufflation gas conditioning system control unit | A mains electricity (AC-powered) device designed to be used together with a laparoscopic gas distention system or other gas source to condition the insufflation gas stream [typically carbon dioxide (CO2)] by automatically heating and humidifying the gas before introduction into the peritoneal cavity or a wound during laparoscopic or open surgery. It is electronically controlled and has controls and displays for the user to operate and monitor the gas conditioning process which happens within an interchangeable humidification chamber that is fitted to this device. The gas is delivered to the operative site via a dedicated heated tubing set. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00885554011203 | GS1 |
Customer Contacts
- Phone
- +1(800)821-5700
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K022052 | 000 |