Identity
- Trade Name
- Plan 1 Health FDA UDI
- Generic Name
- Urinary catheter holder FDA UDI
- Device Name
- Catheter Securement for Bard PICC & CVC, Intended for further processing FDA UDI
- Model / Reference
- 01.60.70.10 FDA UDI
- Description
- Catheter Securement for Bard PICC & CVC, Intended for further processing FDA UDI
Identifiers
- Catalog Number
- 01.60.70.10 FDA UDI
- Primary DI / UDI-DI
- 00618125143863 FDA UDI
- FDA Product Code
- KMK FDA UDI
- GMDN Term
- Urinary catheter holder FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.5210 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
Category: Urinary catheter holder
Plan 1 Health by Tidi Products, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Urinary catheter holder.
- Centurion — Centurion Medical Products · Class I
- Centurion — Centurion Medical Products · Class I
- Marpac Inc — Marpac, Inc. · Class I
- Medline — MEDLINE INDUSTRIES, INC. · Class I
- 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
- Tidi Products, Llc
Sources (1)
- FDA UDI b8130dc6-3713-41b7-8ae3-fab89f70d85d 34 fields · synced May 30, 2026