Identity
- Trade Name
- MEDLINE INDUSTRIES, INC. FDA UDI
- Generic Name
- Temperature-monitoring indwelling urethral drainage catheter FDA UDI
- Device Name
- 1LYR 6FR1.5ML 100%SIL TMP PEDS FDA UDI
- Model / Reference
- DYND160806T FDA UDI
- Description
- 1LYR 6FR1.5ML 100%SIL TMP PEDS FDA UDI
Identifiers
- Catalog Number
- DYND160806T FDA UDI
- Primary DI / UDI-DI
- 10889942148226 FDA UDI
- FDA Product Code
- OHR FDA UDI
- GMDN Term
- Temperature-monitoring indwelling urethral drainage catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5130 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Dimensions & Sizes
- Size
- Catheter Gauge — 6 French FDA UDITotal Volume — 3 Milliliter FDA UDI
Category: Indwelling urethral catheterization kit, adultTemperature-monitoring indwelling urethral drainage catheter
Medline Industries, Inc. by Medline Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Temperature-monitoring indwelling urethral drainage catheter.
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- Covidien AG — DEGANIA SILICONE LTD · Class II
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
- TEMPERATURE SENSING FOLEY BALLOON CATHETER — Sewoon Medical Co., Ltd. · Class II
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 II | Pending data |
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Manufacturer
- Manufacturer
- Medline Industries, Inc.
Sources (1)
- FDA UDI 1a3b549f-ea1a-47bb-b7b0-099443f2834a 36 fields · synced May 30, 2026