Identity
- Trade Name
- 9Line FDA UDI
- Generic Name
- Urinary catheter holder FDA UDI
- Device Name
- Disposable SafeDwell Foley Catheter Monitor with Securement BX of 25 FDA UDI
- Model / Reference
- R-8675309 FDA UDI
- Description
- Disposable SafeDwell Foley Catheter Monitor with Securement BX of 25 FDA UDI
Identifiers
- Catalog Number
- R-8675309 FDA UDI
- Primary DI / UDI-DI
- G0960R86753090 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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Urinary catheter holder
9Line by Rising Eagle Medical — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Urinary catheter holder.
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- 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
- Rising Eagle Medical
Sources (1)
- FDA UDI 160e5715-26a7-4cf2-8feb-786f9687f8be 34 fields · synced May 30, 2026