Identity
- Trade Name
- 200mL Sterile Disposable Qwik-Fit Syringe FDA UDI
- Generic Name
- Angiographic syringe FDA UDI
- Device Name
- Envision, Vistron, MCT- 200 ml syringe (CT - 200ML ENV/VIST SYRINGE KIT) (60728621) FDA UDI
- Model / Reference
- 200-FLS FDA UDI
- Description
- Envision, Vistron, MCT- 200 ml syringe (CT - 200ML ENV/VIST SYRINGE KIT) (60728621) FDA UDI
Identifiers
- Catalog Number
- 200-FLS FDA UDI
- Primary DI / UDI-DI
- 00616258005508 FDA UDI
- 510(k) Number
- K924116 FDA UDI
- FDA Product Code
- DXT FDA UDI
- GMDN Term
- Angiographic syringe FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1650 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
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
Yes
FDA UDI
Category: Angiographic syringe
200mL Sterile Disposable Qwik-Fit Syringe by Bayer Medical Care Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K924116 also covers:
- 200mL Sterile Disposable Qwik-Fit Syringe — Bayer Medical Care Inc.
- 200mL Sterile Disposable Qwik-Fit Syringe — Bayer Medical Care Inc.
- 200mL Sterile Disposable Qwik-Fit Syringe & QFT — Bayer Medical Care Inc.
- 200mL Sterile Disposable Qwik-Fit Syringe & QFT — Bayer Medical Care Inc.
- 200mL Sterile Disposable Qwik-Fit Syringe & QFT — Bayer Medical Care Inc.
- 200mL Sterile Disposable Qwik-Fit Syringe & QFT — Bayer Medical Care Inc.
- ASSY, CBL, RPC, MN, SHLD, START, SW, UDI, BATCH — Bayer Medical Care Inc.
- CABLE, START SWITCH, 25FT, 4PIN, UDI, BATCH — Bayer Medical Care Inc.
- CT TRI-PAK Sterile Disposable Syringe — Bayer Medical Care Inc.
- CT TRI-PAK Sterile Disposable Syringe — Bayer Medical Care Inc.
- CT TRI-PAK Sterile Disposable Syringe — Bayer Medical Care Inc.
- CT TRI-PAK Sterile Disposable Syringe — Bayer Medical Care Inc.
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
- Bayer Medical Care Inc.
Sources (1)
- FDA UDI e73eb836-05f6-4697-b0e7-f3f9b48a47d3 36 fields · synced Jun 9, 2026