FDA UDI
In Commercial Distribution
🇺🇸 United States
Bio-logic
DI: 00382830052290
·
Model: Insert Earphone Tip ER2 Pediatric
·
NATUS MEDICAL INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
Basic Information
- Brand Name
- Bio-logic
- Primary DI
- 00382830052290
- Version / Model
- Insert Earphone Tip ER2 Pediatric
- Catalog Number
- 202124
- Company Name
- NATUS MEDICAL INCORPORATED
- Labeler DUNS
- 962519208
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2017-04-03
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- c825f756-6226-414a-9b3f-7dc3f100002b
Device Description
ER2/Broadband Insert Earphone Disposable Foam Tips for pediatric and for use with 580-ER2INS
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- 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
- 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 |
|---|---|---|---|---|
| EWO | Audiometer | Ear, Nose, Throat | 874.1050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62133 | Audiometric ear tip | A non-sterile luminal device intended to be connected to the distal end of an audiometric sound delivery tube and inserted into the ear canal, to allow test sounds to be delivered to the ear in isolation from background noise. It is designed to create a seal inside the ear canal whilst allowing the sound tube to pass through the lumen. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00382830052290 | GS1 | ||||
| Unit of Use | 00382830054317 | GS1 |
Customer Contacts
- Phone
- 1-800-303-0306
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K031352 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 9.1 | Millimeter | |
| Length | 11.6 | Millimeter |