Identity
- Trade Name
- Apogee Plus FDA UDI
- Generic Name
- Single-administration urethral drainage catheter FDA UDI
- Device Name
- Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Kit, Firm, 10 Fr 16 in, Straight FDA UDI
- Model / Reference
- B10FB FDA UDI
- Description
- Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Kit, Firm, 10 Fr 16 in, Straight FDA UDI
Identifiers
- Catalog Number
- B10FB FDA UDI
- Primary DI / UDI-DI
- 20610075177206 FDA UDI
- 510(k) Number
- K032710 FDA UDI
- FDA Product Code
- FCM FDA UDI
- GMDN Term
- Single-administration 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
No
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
- Length — 16 Inch FDA UDICatheter Gauge — 10 French FDA UDI
Category: Single-administration urethral drainage catheter
Apogee Plus by Hollister Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Single-administration urethral drainage catheter.
- CURE ULTRA MALE CATHETER — CONVATEC, PURCHASING DEPARTMENT · Class II
- Bardex® Urethral Catheter Robinson Model — C. R. Bard, Inc. · Class II
- Self-Cath — Coloplast A/S · Class II
- CURE CATHETER — CONVATEC, PURCHASING DEPARTMENT · Class II
- Magic3™ Intermittent Catheter — C. R. Bard, Inc. · Class II
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
- CURE ULTRA MALE CATHETER — CONVATEC, PURCHASING DEPARTMENT · Class II
- Bard® Rubber Utility Catheter — C. R. Bard, Inc. · Class II
Cleared under the same submission
K032710 also covers:
- Apogee Plus — Hollister Incorporated
- Apogee Plus — Hollister Incorporated
- Apogee Plus — Hollister Incorporated
- Apogee Plus — Hollister Incorporated
- Apogee Plus — Hollister Incorporated
- Apogee Plus — Hollister Incorporated
- Apogee Plus — Hollister Incorporated
- Apogee Plus — Hollister Incorporated
- Apogee Plus — Hollister Incorporated
- Apogee Plus — Hollister Incorporated
- Apogee Plus — Hollister Incorporated
- Apogee Plus — Hollister Incorporated
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hollister Incorporated
Sources (1)
- FDA UDI a0d638eb-97f0-4f73-976e-5ff2b0d63000 37 fields · synced Jun 9, 2026