FDA UDI
In Commercial Distribution
🇺🇸 United States
Neptune
DI: 07613327471519
·
Model: 0703-045-100
·
STRYKER CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Neptune
- Primary DI
- 07613327471519
- Version / Model
- 0703-045-100
- Catalog Number
- 0703-045-100
- Company Name
- STRYKER CORPORATION
- Labeler DUNS
- 196548481
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-10-17
- Public Version
- 3
- Public Version Date
- 2020-07-01
- Public Version Status
- Update
- Public Device Record Key
- 6b41050f-a680-49ff-b8d4-07c2370cc6df
Device Description
Smoke Tubing, Canister, Fluid Trap
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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QGI | Air-handling apparatus accessory | General, Plastic Surgery | 878.5080 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31723 | Suction system filter, plume particulate | A screening device installed within the suction tubing line of a suction system, or the suction tubing used with a central vacuum system, to extract particulates from the plume of smoke created typically through the use of various tissue-burning surgical devices (e.g., laser, electrosurgical diathermy device), to prevent clogging of the suction or vacuum system. It will typically have a hydrophobic membrane that retains the particulate/bacterial pathogens through a combination of mechanical, electrostatic, or other means. The device comes in various sizes and designs and can be made of translucent plastic, allowing for inspection when in use. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 57613327471514 | GS1 | case | 2 | In Commercial Distribution | |
| Package | 37613327471510 | GS1 | pack | 5 | In Commercial Distribution | |
| Primary | 07613327471519 | GS1 |
Customer Contacts
- Phone
- +0018002533210
- [email protected]
Storage Conditions
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 75 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 78 – 106 KiloPascal
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 35 Degrees Celsius