FDA UDI
In Commercial Distribution
🇺🇸 United States
CUSTOM SND SUITE 1.3 SERV RELEASE 1
DI: 09321502011624
·
Model: Z61155
·
COCHLEAR LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CUSTOM SND SUITE 1.3 SERV RELEASE 1
- Primary DI
- 09321502011624
- Version / Model
- Z61155
- Catalog Number
- Z61155
- Company Name
- COCHLEAR LIMITED
- Labeler DUNS
- 750551194
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-24
- Public Version
- 5
- Public Version Date
- 2023-11-03
- Public Version Status
- Update
- Public Device Record Key
- dc0077ee-b23d-42d6-a14e-ef2888b152c1
Device Description
CUSTOM SND SUITE 1.3 SERV RELEASE 1
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| MCM | IMPLANT, COCHLEAR | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60211 | Audiometric/hearing device software | A software program intended to assist with the evaluation of a patient’s hearing capability and/or evaluate and adjust the settings of a hearing assistive device. It may be used by healthcare professionals in a healthcare facility or by the patient in the home, and intended to be used on a non-medical computerized device (e.g., smartphone, tablet). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09321502011624 | GS1 |
Customer Contacts
- Phone
- +1(800)523-5798
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P970051 | 000 |
Storage Conditions
- Type
- Handling Environment Humidity
- Temperature Range
- 0 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 50 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- -20 – 50 Degrees Celsius