FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Atos Medical
DI: 00817126020122
·
Model: 9/55
·
ATOS MEDICAL INC.
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Atos Medical
- Primary DI
- 00817126020122
- Version / Model
- 9/55
- Catalog Number
- 2010-07E6
- Company Name
- ATOS MEDICAL INC.
- Labeler DUNS
- 008224748
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-11-17
- Public Version
- 4
- Public Version Date
- 2022-04-05
- Public Version Status
- Update
- Public Device Record Key
- 3dc1101a-8ad1-4e1b-9148-2c7df8c39606
- Distribution End Date
- 2022-03-31
Device Description
Laryngectomy Pulmonary Kit 9/55 With Provox® Standard LaryTube™ and Liberty™ Electrolarynx
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Conditional
- 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
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42533 | Tracheoesophageal speech valve, indwelling | A device designed to be inserted into a surgically-created tracheo-oesophageal fistula after total laryngectomy to provide the patient with voice restoration. It is inserted and replaced on an as needed basis by a speech pathologist or clinician. It has a double flange (one on the outside of the throat and one on the inside) to hold it in place and includes a one-way valve that protects the airway during swallowing and opens under positive pressure so that air crosses into the oesophagus to produce voice (speech rehabilitation). The patient periodically cleans the device in situ. Disposable devices associated with implantation/insertion may be included. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00817126020122 | GS1 |
Customer Contacts
- Phone
- 800-217-0025
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry. Do not store in direct sunlight.
- Type
- Handling Environment Temperature
- Temperature Range
- 36 – 108 Degrees Fahrenheit