FDA UDI
In Commercial Distribution
🇺🇸 United States
SILENTE, INTERSURGICAL ECOLITE™, ADULT, ADJUSTABLE VENTURI MASK KIT AND TUBE
DI: 05030267157877
·
Model: 1137016
·
Intersurgical Incorporated
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- SILENTE, INTERSURGICAL ECOLITE™, ADULT, ADJUSTABLE VENTURI MASK KIT AND TUBE
- Primary DI
- 05030267157877
- Version / Model
- 1137016
- Company Name
- Intersurgical Incorporated
- Labeler DUNS
- 785952607
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-11-09
- Public Version
- 1
- Public Version Date
- 2023-11-17
- Public Version Status
- New
- Public Device Record Key
- e826925f-fdec-4672-8508-6b1fa8843d92
Device Description
SILENTE, INTERSURGICAL ECOLITE™, ADULT, ADJUSTABLE VENTURI MASK KIT AND TUBE WITH UNIVERSAL CONNECTOR, 1.8M
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Unsafe
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BYG | Mask, Oxygen | Anesthesiology | 868.5580 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35175 | Venturi oxygen face mask | A flexible, form-shaped device designed to be placed over the nose and mouth to deliver a near-precise mixture of air and oxygen (O2) to a patient's airway without the use of a gas mixer. The device typically includes a variety of exchangeable inserts (the venturi) that allow air entrainment in controlled amounts to provide the desired O2 concentration. It is connected to an O2 source with tubing and includes headstraps for stabilization. Adaptors are typically included for connection to a humidification source. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05030267163533 | GS1 | 30 | In Commercial Distribution | ||
| Primary | 05030267157877 | GS1 |
Customer Contacts
- Phone
- 3154512900
- [email protected]