Identity
- Trade Name
- Medline FDA UDI
- Generic Name
- Otoscope, direct FDA UDI
- Device Name
- OTOSCOPE,POCKET,2.5V LED,W/POUCH FDA UDI
- Model / Reference
- MDS3000LOT FDA UDI
- Description
- OTOSCOPE,POCKET,2.5V LED,W/POUCH FDA UDI
Identifiers
- Catalog Number
- MDS3000LOT FDA UDI
- Primary DI / UDI-DI
- 00193489136237 FDA UDI
- FDA Product Code
- ERA FDA UDI
- GMDN Term
- Otoscope, direct FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.4770 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Otoscope, direct
Medline by Medline Industries, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Otoscope, direct.
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- Welch Allyn, Inc. — Welch Allyn, Inc. · Class I
- Safety 1st — DOREL JUVENILE GROUP, INC. · Class I
- BETA 200 VET. OTOSCOPE — Heine Optotechnik GmbH & Co. KG · Class I
- Firefly — Firefly Global · Class I
- Otoscope — Shenzhen Teslong Technology Co., Ltd · Class I
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Medline Industries, Inc.
Sources (1)
- FDA UDI 66c53ad9-2032-41b6-8850-783dbe3a1ef6 36 fields · synced May 30, 2026