FDA UDI
In Commercial Distribution
🇺🇸 United States
inspired™
DI: 14896138000950
·
Model: 2096534-008
·
VINCENT MEDICAL MANUFACTURING CO., LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- inspired™
- Primary DI
- 14896138000950
- Version / Model
- 2096534-008
- Company Name
- VINCENT MEDICAL MANUFACTURING CO., LIMITED
- Labeler DUNS
- 663901361
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-18
- Public Version
- 3
- Public Version Date
- 2024-03-26
- Public Version Status
- Update
- Public Device Record Key
- 5861b544-4599-4717-b2d3-cc06854032c3
Device Description
PATIENT CIRCUIT KIT,PEDIATRIC,REUSABLE,HYTREL
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | Anesthesiology | 868.5240 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37021 | Anaesthesia breathing circuit, reusable | An assembly of devices designed to conduct medical gases from an anaesthesia unit/workstation to a patient artificial airway/anaesthesia mask (not included) during general anaesthesia. It includes breathing tubes and a Y-piece connector, typically with a ventilator/ventilation bag and appropriate connectors, and may include a carbon dioxide (CO2) absorber, a one-way directional valve, or adjustable pressure limiting (APL) valve. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 64896138000955 | GS1 | Case | 10 | In Commercial Distribution | |
| Primary | 14896138000950 | GS1 |