MEDRAD® Intego Sterile Disposables
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Sterile Disposables EUDAMEDMEDRAD® Intego Sterile Disposables FDA UDI
- Generic Name
- Electric infusion pump administration set, single-use FDA UDI
- Device Name
- CT TRI-PAK Sterile Disposable Syringe EUDAMEDASSY,TBG,SAS,SPIKE,T-CONN,MC,CORE (87640477) FDA UDI
- Model / Reference
- LPDCT 50 EUDAMEDINT CSS FDA UDI
- Description
- ASSY,TBG,SAS,SPIKE,T-CONN,MC,CORE (87640477) FDA UDI
Identifiers
- Catalog Number
- INT CSS FDA UDI
- Primary DI / UDI-DI
- 00616258023212 EUDAMED00616258024837 FDA UDI
- Basic UDI-DI
- 0616258TFCN-0009Q8 EUDAMED
- 510(k) Number
- K080297 FDA UDI
- FDA Product Code
- FRN FDA UDI
- EMDN Code
- A03020101 LOW PRESSURE EXTENSION LINES EUDAMED
- GMDN Term
- Electric infusion pump administration set, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5725 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Electric infusion pump administration set, single-use
MEDRAD® Intego Sterile Disposables by Bayer Medical Care Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Electric infusion pump administration set, single-use.
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Cleared under the same submission
K080297 also covers:
- MEDRAD® Intego PET Infusion System — Bayer Medical Care Inc.
- MEDRAD® Intego PET Infusion System — Bayer Medical Care Inc.
- MEDRAD® Intego PET Infusion System — Bayer Medical Care Inc.
- MEDRAD® Intego PET Infusion System — Bayer Medical Care Inc.
- MEDRAD® Intego PET Infusion System — Bayer Medical Care Inc.
- MEDRAD® Intego PET Infusion System — Bayer Medical Care Inc.
- MEDRAD® Intego PET Infusion System — Bayer Medical Care Inc.
- MEDRAD® Intego Patient Administration Set — Bayer Medical Care Inc.
- MEDRAD® Intego Patient Administration Set — Bayer Medical Care Inc.
- MEDRAD® Intego Sterile Disposables — Bayer Medical Care Inc.
- MEDRAD® Intego Sterile Disposables — Bayer Medical Care Inc.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Bayer Medical Care Inc.
Sources (2)
- FDA UDI 6f149fe4-47ad-4aa5-91af-2c3f37fb20bc 38 fields · synced Jul 21, 2026
- EUDAMED 53c6689d-f66d-400d-90a8-5b59e528f30d 61 fields · synced Jul 21, 2026