Welch Allyn, Inc.
- Primary DI
- 00732094101997
- Brand
- Welch Allyn, Inc.
- Company
- WELCH ALLYN, INC.
- Model
- 901026
- Catalog number
- 97810-MC
- Device description
- Welch Allyn 3.5 V Halogen HPX Diagnostic Set including PanOptic Ophthalmoscope with Cobalt-Blue Filter and Corneal Viewing Lens (#11 820), MacroView Otoscope with Throat Illuminator (#23820), Nasal Illuminator (#26535), Rechargeable 60-Minute Power Handle(s) -- C-Cell Convertible, Hard Storage Case, C-Cell Battery Converter Accessory; Nickel-Cadmiu
- Published
- 2016-09-17
- Public version status
- Update
- 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 |
|---|
| 00732094101997 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00732094101997 | 00732094101997 | 732094101997 | 0732094101997 |
GMDN Terms
| Term | Definition |
|---|
| Otoscope, direct | A portable, battery-powered, hand-held device (non-endoscopic) primarily designed for examination of the outer ear canal and tympanic membrane (eardrum) by direct viewing through the ear opening. The device consists of a handle that contains the batteries (which may be rechargeable), a built-in light to illuminate the interior of the ear canal, and a detachable cone-shaped tube (the speculum) that is inserted in the ear canal. In some cases a moderate air pressure may be applied. Supplemental devices (e.g., additional specula, spare light bulbs) may be included. This is a reusable device. |
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
- false
- 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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