Identity
- Trade Name
- Foley Tie FDA UDI
- Generic Name
- Urinary catheter holder FDA UDI
- Device Name
- Foley Catheter Legband FDA UDI
- Model / Reference
- 606 FDA UDI
- Description
- Foley Catheter Legband FDA UDI
Identifiers
- Catalog Number
- 606 FDA UDI
- Primary DI / UDI-DI
- 00850014574185 FDA UDI
- FDA Product Code
- EYJ FDA UDI
- GMDN Term
- Urinary catheter holder FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.5130 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Category: Urinary catheter holder
Foley Tie by Pepper Medical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Urinary catheter holder.
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- MediChoice — OWENS & MINOR DISTRIBUTION, INC. · Class I
- CATH-SECURE PLUS — M. C. JOHNSON CO., INC. · Class I
- Catheter Stabilization Device — C. R. Bard, Inc. · Class I
- Medline — MEDLINE INDUSTRIES, 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
- Pepper Medical, Inc.
Sources (1)
- FDA UDI 7961d460-0e6a-43c9-8570-fa5ed5e11516 35 fields · synced Jun 1, 2026