Welch Allyn, Inc.
- Primary DI
- 00732094086089
- Brand
- Welch Allyn, Inc.
- Company
- WELCH ALLYN, INC.
- Model
- 901001
- Catalog number
- 22003
- Device description
- Welch Allyn 3.0 mm Reusable Ear Specula for Pneumatic, Operating, and Consulting Otoscopes
- Published
- 2023-08-17
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| ERA | Otoscope | Ear, Nose, Throat | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00732094086089 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00732094086089 | 00732094086089 | 732094086089 | 0732094086089 |
GMDN Terms
| Term | Definition |
|---|
| 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. |
Regulatory Flags
- DUNS number
- 198227881
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| 00732094055245 | Welch Allyn, Inc. | 901001 | SM2551 | 2026-03-06 |
| 00887761976283 | Life2000 | MS-01-0125 | | 2026-02-09 |
| 00887761978041 | Life2000 | MS-01-0121 | | 2026-02-09 |
| 00732094360363 | Welch Allyn, Inc. | 901144 | QS-6AA-AEAAA | 2026-02-03 |
| 00732094360370 | Welch Allyn, Inc. | 901144 | XSCRIBE-6AA-ACAAA | 2026-02-03 |
| 00732094360295 | Welch Allyn, Inc. | 901204 v7.4.2 | E10001 | 2025-12-18 |
| 00732094357929 | Welch Allyn, Inc. | 901026 | 71-XM2LXE | 2025-11-25 |
| 00732094358933 | Welch Allyn, Inc. | 901203 | C360KIT95RXTBWLJBP | 2025-11-24 |
| 00732094358957 | Welch Allyn, Inc. | 901203 | C360KIT95MXTBWLJBP | 2025-11-24 |
| 00732094358971 | Welch Allyn, Inc. | 901203 | C360KIT95CXTBWLJBP | 2025-11-24 |
| 00732094358988 | Welch Allyn, Inc. | 901203 | C360KIT95CXTBMBJX | 2025-11-24 |
| 00732094237740 | Welch Allyn, Inc. | 901049 | CP150A | 2025-09-22 |
| 00732094356366 | Welch Allyn, Inc. | 901006 | 9293-046-57 | 2025-09-22 |
| 00732094356373 | Welch Allyn, Inc. | 901006 | 9293-046-55 | 2025-09-22 |
| 00732094356380 | Welch Allyn, Inc. | 901006 | 9293-046-06 | 2025-09-22 |
| 00732094356397 | Welch Allyn, Inc. | 901006 | 9293-046-05 | 2025-09-22 |
| 00732094356403 | Welch Allyn, Inc. | 901006 | 9293-046-04 | 2025-09-22 |
| 00732094356410 | Welch Allyn, Inc. | 901006 | 9293-046-03 | 2025-09-22 |
| 00732094309225 | Welch Allyn, Inc. | 901057 | 44XT | 2021-04-26 |
| 06932825304237 | Welch Allyn, Inc. | 901123 | 2000 PLUS-A | 2025-08-08 |
Other Devices Sharing Product Codes
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