FDA UDI
In Commercial Distribution
🇺🇸 United States
Optitherm
DI: 04048551068663
·
Model: 20432030
·
Karl Storz GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Optitherm
- Primary DI
- 04048551068663
- Version / Model
- 20432030
- Company Name
- Karl Storz GmbH & Co. KG
- Labeler DUNS
- 315731430
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 182d3b53-2d11-4733-a799-51f6f7b07da9
Device Description
Optitherm® Heating Element
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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HIF | INSUFFLATOR, LAPAROSCOPIC | Obstetrics/Gynecology | 884.1730 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48168 | Insufflation gas conditioning system | An assembly of devices used with a laparoscopic gas distention system or other gas source to condition the insufflation gas stream [typically carbon dioxide (CO2)] by heating and humidifying the gas before introduction into the peritoneal cavity or a wound during laparoscopic or open surgery. It typically consists of a mains electricity (AC-powered) control unit, a humidification chamber through which cold/dry gas passes for conditioning, and a tubing set for connection to the gas source and delivery of the conditioned gas to the operative site. Conditioning of the gas helps alleviate problems associated with gas insufflation, i.e., desiccation of internal tissue and body temperature loss. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04048551068663 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K955073 | 000 |