FDA UDI
In Commercial Distribution
🇺🇸 United States
Trilogy
DI: 00606959026162
·
Model: Trilogy Passive Exhalation Circuit, Pediatric
·
Respironics, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Trilogy
- Primary DI
- 00606959026162
- Version / Model
- Trilogy Passive Exhalation Circuit, Pediatric
- Catalog Number
- 1052127
- Company Name
- Respironics, Inc.
- Labeler DUNS
- 080728314
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-23
- Public Version
- 6
- Public Version Date
- 2021-02-22
- Public Version Status
- Update
- Public Device Record Key
- 24f961b6-083b-48ee-af9a-b8f3dda49de0
Device Description
Trilogy Ventilator Passive Exhalation Circuit, Pediatric circuit
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
- 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 |
|---|---|---|---|---|
| CBK | VENTILATOR, CONTINUOUS, FACILITY USE | Anesthesiology | 868.5895 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37705 | Ventilator breathing circuit, reusable | An assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator, or other air-delivery therapeutic device such as a mechanical insufflator/exsufflator, to a patient. It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00606959026162 | GS1 |
Customer Contacts
- Phone
- +1 724-387-4000
- [email protected]
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 15 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -4 – 140 Degrees Fahrenheit