FDA UDI
In Commercial Distribution
🇺🇸 United States
Welch Allyn, Inc.
DI: 00732094107579
·
Model: 901001
·
WELCH ALLYN, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
48
Basic Information
- Brand Name
- Welch Allyn, Inc.
- Primary DI
- 00732094107579
- Version / Model
- 901001
- Catalog Number
- 52700-B
- Company Name
- WELCH ALLYN, INC.
- Labeler DUNS
- 198227881
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 48
- Record Status
- Published
- Publish Date
- 2020-06-22
- Public Version
- 2
- Public Version Date
- 2021-05-10
- Public Version Status
- Update
- Public Device Record Key
- 417ad842-853c-4264-8bb3-a3982d1fdc12
Device Description
Welch Allyn KleenSpec Disposable Ear Specula with Instrumentation Slot; Compatible with MacroView Otoscopes (#23810, #23820); Qty. 48
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| ERA | OTOSCOPE | Ear, Nose, Throat | 874.4770 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12849 | Otoscope, direct | An electrically-powered, hand-held device designed for examination of the outer ear canal and tympanic membrane (eardrum) by direct viewing through the ear opening. It consists of a main unit (commonly referred to as the head) with a built-in light source intended to illuminate the interior of the ear canal with a detachable cone-shaped tube (speculum) inserted in the ear canal; it may facilitate the application of air pressure for pneumatic otoscopy. A dedicated power supply handpiece and/or an insufflation bulb may be included with the head. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00732094144048 | GS1 | 4 | In Commercial Distribution | ||
| Primary | 00732094107579 | GS1 | ||||
| Unit of Use | 00732094216073 | GS1 |
Customer Contacts
- Phone
- +1(315)685-2834
- [email protected]