Welch Allyn, Inc.
- Primary DI
- 00732094085013
- Brand
- Welch Allyn, Inc.
- Company
- WELCH ALLYN, INC.
- Model
- 901001
- Catalog number
- 23305
- Device description
- Welch Allyn AudioSpec 5.0 mm Reusable Ear Specula for AudioScope
- 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 |
|---|
| EWO | Audiometer | Ear, Nose, Throat | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00732094085013 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00732094085013 | 00732094085013 | 732094085013 | 0732094085013 |
GMDN Terms
| Term | Definition |
|---|
| Impedance audiometer | An electronic instrument used to evaluate the functional condition of the middle ear by changing the air pressure in the external auditory canal to measure and graph the mobility characteristics of the tympanic membrane. It identifies abnormalities in tympanic membrane mobility due to stiffness, flaccidity, or the presence of fluid in the middle ear cavity. The device is also used to measure the acoustic reflex threshold from contractions of the stapedial muscle, to monitor healing of tympanic membrane grafts or stapedectomies, or to monitor follow up treatment for inflammation of the middle ear. |
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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