FDA UDI
In Commercial Distribution
🇺🇸 United States
Sechrist Industries, Inc.
DI: 00852682007361
·
Model: 23065-1
·
SECHRIST INDUSTRIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Sechrist Industries, Inc.
- Primary DI
- 00852682007361
- Version / Model
- 23065-1
- Company Name
- SECHRIST INDUSTRIES, INC.
- Labeler DUNS
- 062084215
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-06-30
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- cfdb8795-15f4-4f64-8e0e-879aa881b030
Device Description
CNTRL MOD,MILLENNIUM,ENGLISH
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| ONZ | Mechanical Ventilator | Anesthesiology | 868.5895 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 14361 | Neonatal intensive-care ventilator | A mains electricity (AC-powered) automatic cycling device intended for short-term and long-term ventilatory support for a neonatal/paediatric patient, especially those preterm and critically ill with respiratory failure in a critical care setting. It is typically a time-cycled, pressure-control device that includes a small bore flexible tube breathing system. It may be capable of high frequency oscillatory ventilation in addition to conventional ventilation, and includes positive end-expiratory pressure (PEEP) and continuous positive airway pressure (CPAP) controls. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00852682007361 | GS1 |
Customer Contacts
- Phone
- 7145798400
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Depth | 18 | Inch | |
| Width | 15 | Inch | |
| Height | 22 | Inch | |
| Weight | 35 | Pound |