Identity
- Trade Name
- Collecting Bag 2000ml (Straub Medical®) FDA UDI
- Generic Name
- Non-wearable adult urine collection bag, closed-ended FDA UDI
- Device Name
- The collecting bag is non-patient contacting and is attached to the silicon outflow tube on the proximal end of the catheter. The fluid aspirated by the catheter passes through the catheters’ outflow tubing into the Collecting bag. FDA UDI
- Model / Reference
- Version 1.0 FDA UDI
- Description
- The collecting bag is non-patient contacting and is attached to the silicon outflow tube on the proximal end of the catheter. The fluid aspirated by the catheter passes through the catheters’ outflow tubing into the Collecting bag. FDA UDI
Identifiers
- Catalog Number
- 10170 FDA UDI
- Primary DI / UDI-DI
- 07640142810612 FDA UDI
- 510(k) Number
- K172315 FDA UDI
- FDA Product Code
- KNX FDA UDI
- GMDN Term
- Non-wearable adult urine collection bag, closed-ended FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5250 FDA UDI
- Commercial Distribution
- Not 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
No
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
- Total Volume — 2000 Milliliter FDA UDI
Collecting Bag 2000ml (Straub Medical®) by Straub Medical AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K172315 also covers:
- Drive System (Straub Medical®) — Straub Medical AG
- Guidewire 0.018 4/220cm angled (Straub Medical®) — Straub Medical AG
- Guidewire 0.018 4/270cm angled (Straub Medical®) — Straub Medical AG
- Guidewire 0.018 4/320cm angled (Straub Medical®) — Straub Medical AG
- SET Rotarex™S 6 F x 110 cm — Straub Medical AG
- SET Rotarex™S 6 F x 135 cm — Straub Medical AG
- SET Rotarex™S 8 F x 110 cm — Straub Medical AG
- SET Rotarex™S 8 F x 85 cm — Straub Medical AG
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
- Straub Medical AG
Sources (1)
- FDA UDI 3a30fe23-eb0a-45a3-82d8-6ec76fe85264 38 fields · synced May 30, 2026