FDA UDI
In Commercial Distribution
🇺🇸 United States
RUSCH
DI: 04026704002672
·
Model: IPN040900
·
TELEFLEX INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- RUSCH
- Primary DI
- 04026704002672
- Version / Model
- IPN040900
- Catalog Number
- 102004-000070
- 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
- 3
- Public Version Date
- 2019-06-03
- Public Version Status
- Update
- Public Device Record Key
- e3444b69-92c9-4c04-b5ae-a89b525ab917
Device Description
Endotracheal tube for laser surgery
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- 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 |
|---|---|---|---|---|
| 36064 | Laser-resistant endotracheal tube | A hollow cylinder that is inserted into the trachea used to secure airway patency and/or for anaesthesia administration, and which is not damaged or easily set on fire if inadvertently irradiated by a laser beam during surgery around the head, throat, or neck. This device would typically be employed when laser surgery is being applied to the patient's head/neck area. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 24026704002676 | GS1 | Box | 2 | In Commercial Distribution | |
| Primary | 04026704002672 | GS1 | ||||
| Package | 44026704002670 | GS1 | Carton | 46 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(919)544-8000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K935842 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Lumen/Inner Diameter | 7 | Millimeter | |
| Device Size Text, specify | 7.0 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight; Keep dry