FDA UDI
In Commercial Distribution
🇺🇸 United States
Welch Allyn, Inc.
DI: 00732094048407
·
Model: 901001
·
WELCH ALLYN, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Welch Allyn, Inc.
- Primary DI
- 00732094048407
- Version / Model
- 901001
- Catalog Number
- 406513
- Company Name
- WELCH ALLYN, INC.
- Labeler DUNS
- 198227881
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-03-19
- Public Version
- 2
- Public Version Date
- 2022-06-21
- Public Version Status
- Update
- Public Device Record Key
- ee6f646f-51bc-47fb-8fc7-af13ab1fcb43
Device Description
MICROTYMP 3 TIPS - 4 LARGE GREEN
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ETY | Tester, auditory impedance | Ear, Nose, Throat | 874.1090 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31940 | Earphone cushion | A device that is part of an earphone, sometimes detachable, which rests against the ear or head. In the case of audiometric ear phones the cushion is part of the specification for calibration purposes. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00732094048407 | GS1 |
Customer Contacts
- Phone
- +1(315)685-2834
- [email protected]