FDA UDI
In Commercial Distribution
🇺🇸 United States
Orantech
DI: 06941691969327
·
Model: TNC-RP-AA001
·
Orantech Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Orantech
- Primary DI
- 06941691969327
- Version / Model
- TNC-RP-AA001
- Company Name
- Orantech Inc.
- Labeler DUNS
- 544423370
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-01-24
- Public Version
- 1
- Public Version Date
- 2024-02-01
- Public Version Status
- New
- Public Device Record Key
- 034fd1dd-7aaa-442f-bdca-ae88becf20c5
Device Description
Replacement Disposable Sidestream ETCO2 Capnotrak Airway Adapter Set 4.0mm For Adult Respironics 1103414 Philips 989803198991
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
- Yes
- 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 |
|---|---|---|---|---|
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | Anesthesiology | 868.5240 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42327 | Anaesthesia workstation common gas outlet | A device that is a module of an anaesthesia workstation and that is the external port on the gas delivery unit used to convey all flowing gases and vapours from the gas delivery unit to the breathing system. The common gas outlet includes an attachment to the fresh gas supply tube, slip-joint and co-axial connectors, and may have a load-bearing fitting for the secure attachment of accessory equipment. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06941691969327 | GS1 |