FDA UDI
In Commercial Distribution
🇺🇸 United States
Respan®
DI: 10889483300183
·
Model: R-9338
·
SUNMED, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Respan®
- Primary DI
- 10889483300183
- Version / Model
- R-9338
- Catalog Number
- R-9338
- Company Name
- SUNMED, LLC
- Labeler DUNS
- 069009268
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-12-22
- Public Version
- 1
- Public Version Date
- 2025-12-30
- Public Version Status
- New
- Public Device Record Key
- e84e87c1-8421-4eeb-9a72-4b3e264098f5
Device Description
Disposable Anesthesia Breathing Circuit, 60" Adult Anesthesia Circuit, Swivel Wye with Gas Sampling Port
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Package | 20889483300180 | GS1 | Box | 20 | In Commercial Distribution | |
| Primary | 10889483300183 | GS1 | ||||
| Previous | 10889483612163 | GS1 |
Customer Contacts
- Phone
- 1-800-433-2797
- [email protected]