FDA UDI
In Commercial Distribution
🇺🇸 United States
RUSCH
DI: 14026704341013
·
Model: IPN040976
·
TELEFLEX INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- RUSCH
- Primary DI
- 14026704341013
- Version / Model
- IPN040976
- Catalog Number
- 103902095
- Company Name
- TELEFLEX INCORPORATED
- Labeler DUNS
- 002348191
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-16
- Public Version
- 6
- Public Version Date
- 2023-12-06
- Public Version Status
- Update
- Public Device Record Key
- b7473d6e-6088-4337-86b6-3ddfcb2622ba
Device Description
CURVED REINFORCED ENDOTRACEAL TUBE - MURPHY EYE, HIGH VOLUME, LOW PRESSURE CUFF - STERILE PACK
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
- 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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BTR | Tube, tracheal (w/wo connector) | Anesthesiology | 868.5730 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46569 | Reinforced endotracheal tube, single-use | An armoured hollow cylinder inserted orally or nasally into the trachea to provide an unobstructed airway to convey gases and vapours to and from the lungs during anaesthesia, resuscitation, and other situations where the patient is not properly ventilated. It is wire reinforced to prevent kinking during patient movement and may: 1) be packaged with a connector that will attach to a breathing circuit or manual resuscitator; 2) have a distal inflatable cuff to seal against the tracheal wall; 3) have a built-in pilot balloon. It is typically made of plastic or rubber and is available in various diameters and lengths for adult and paediatric patients. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 24026704341010 | GS1 | Box | 5 | Not in Commercial Distribution | 2023-12-01 |
| Primary | 14026704341013 | GS1 | ||||
| Package | 44026704341014 | GS1 | Case | 16 | Not in Commercial Distribution | 2023-12-01 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K990619 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 35 | Millimeter | |
| Width | 35 | Millimeter | |
| Outer Diameter | 12.4 | Millimeter | |
| Length | 399 | Millimeter |