FDA UDI
In Commercial Distribution
🇺🇸 United States
Insufflator
DI: 06971381251357
·
Model: SL101
·
Scivita Medical Technology Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Insufflator
- Primary DI
- 06971381251357
- Version / Model
- SL101
- Company Name
- Scivita Medical Technology Co., Ltd.
- Labeler DUNS
- 544519831
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-02-28
- Public Version
- 3
- Public Version Date
- 2025-06-26
- Public Version Status
- Update
- Public Device Record Key
- 16c2c72b-255f-4f33-b768-8e5f4d6e7957
Device Description
The product is composed of a host and accessories (high pressure tube, pneumoperitoneum tube), and accessories are optional. The Insufflator is a device intended to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.
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
- 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 |
|---|---|---|---|---|
| HIF | Insufflator, Laparoscopic | Obstetrics/Gynecology | 884.1730 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16849 | Laparoscopic insufflator | A mains electricity (AC-powered) device designed to distend the peritoneal cavity by filling it with a pressure-limited gas [typically carbon dioxide (CO2)] providing the operator with a space (pneumoperitoneum) in which to perform an examination or surgical intervention. Electronics assist in monitoring the pressure and maintaining the gas-filled space by compensating for gas leakage. Other surgical instruments may be introduced into the peritoneal cavity through other laparoscopic ports. This device may also be referred to as a gas distention system. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06971381251357 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K222812 | 000 |
Storage Conditions
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Handling Environment Humidity
- Temperature Range
- 20 – 80 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 5 – 40 Degrees Celsius
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 40 – 106 KiloPascal
- Type
- Storage Environment Humidity
- Temperature Range
- 20 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 55 Degrees Celsius