FDA UDI
In Commercial Distribution
🇺🇸 United States
Provox LaryTube Sizerkit
DI: 07331791005329
·
Model: 7648
·
Atos Medical AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Provox LaryTube Sizerkit
- Primary DI
- 07331791005329
- Version / Model
- 7648
- Catalog Number
- 7648
- Company Name
- Atos Medical AB
- Labeler DUNS
- 355470923
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-25
- Public Version
- 1
- Public Version Date
- 2022-12-05
- Public Version Status
- New
- Public Device Record Key
- 940a7a80-101a-4f0f-92d7-cccd5c2a19e7
Device Description
The Provox LaryTube Sizer Kit is intended for use by the prescribing specialist to determine the size(s) of LaryTube that should be prescribed to the patient. The Sizer Kit should be used only by a prescribing specialist who has read the LaryTube Manual. A copy of that manual comes with the Sizer Kit. It can also be viewed on the Internet at www.atosmedical.com. The Sizer LaryTubes are intended for the sizing procedure only. After the correct size(s) have been determined, new LaryTube(s) shall be given to the patient for use.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KAC | Tube, Laryngectomy | Ear, Nose, Throat | 874.4420 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38792 | Tracheostomy tube, non-reinforced, non-customized, reusable | A hollow cylinder designed to be inserted into an artificial opening made in the trachea (windpipe) during a tracheotomy to provide a patent airway; it is not custom-made for a specific patient and is not reinforced with a wire. It is typically constructed of metal [stainless steel, silver (Ag) and/or silver plated brass] or plastic and may include an inner cannula. It is available in cuffed, uncuffed, and/or fenestrated versions, and in a variety of shapes and sizes. It is secured in position by a tracheostomy tube holder fastened around the patient's neck. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07331791005329 | GS1 |
Customer Contacts
- Phone
- +4641519800
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 42 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 36 – 108 Degrees Fahrenheit
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry. Keep away from sunlight