FDA UDI
In Commercial Distribution
🇺🇸 United States
Anesthesia Circuits
DI: 10810050854198
·
Model: PU72
·
TYPENEX MEDICAL LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
40
Basic Information
- Brand Name
- Anesthesia Circuits
- Primary DI
- 10810050854198
- Version / Model
- PU72
- Company Name
- TYPENEX MEDICAL LLC
- Labeler DUNS
- 600850213
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 40
- Record Status
- Published
- Publish Date
- 2022-11-15
- Public Version
- 1
- Public Version Date
- 2022-11-23
- Public Version Status
- New
- Public Device Record Key
- 334652ec-5826-4629-8945-0d7b4222a04f
Device Description
72" Pediatric, Unilimb Circuit
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| BYX | Tubing, Pressure And Accessories | Anesthesiology | 868.5860 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37704 | Anaesthesia breathing circuit, single-use | 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 single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00810050854191 | GS1 | ||||
| Primary | 10810050854198 | GS1 |