FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 00840682103473
·
Model: Ear tips for earphone, 8001233
·
GE Healthcare Finland Oy
Product Codes
6
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- NA
- Primary DI
- 00840682103473
- Version / Model
- Ear tips for earphone, 8001233
- Company Name
- GE Healthcare Finland Oy
- Labeler DUNS
- 401966697
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-06-14
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- e4b2fb8d-100c-4b35-9a12-853fbbfde3b1
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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| GWJ | STIMULATOR, AUDITORY, EVOKED RESPONSE | Neurology | 882.1900 | 2 |
| ORT | Burst suppression detection software for electroencephalograph | Neurology | 882.1400 | 2 |
| OLT | Non-normalizing quantitative electroencephalograph software | Neurology | 882.1400 | 2 |
| MHX | MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) | Cardiovascular | 870.1025 | 2 |
| OMC | Reduced- montage standard electroencephalograph | Neurology | 882.1400 | 2 |
| MLD | MONITOR, ST SEGMENT WITH ALARM | Cardiovascular | 870.1025 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35368 | Auditory stimulator | A mains electricity (AC-powered) device that applies sound stimuli (e.g., pure tones, speech) to a patient's acoustic system. It is typically used as a component of several types of devices such as audiometers, auditory evoked-potential recording systems, and auditory function screening devices. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840682103473 | GS1 |
Customer Contacts
- Phone
- +1(800)558-5120
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K051883 | 000 |