Identity
- Trade Name
- HLS Set FDA UDI
- Generic Name
- Cardiopulmonary bypass system blood tubing set FDA UDI
- Device Name
- HLS Set Advanced 7.0, Adult, BIOLINE Coating FDA UDI
- Model / Reference
- BEQ-HLS 7050 USA FDA UDI
- Description
- HLS Set Advanced 7.0, Adult, BIOLINE Coating FDA UDI
Identifiers
- Catalog Number
- 701069078 FDA UDI
- Primary DI / UDI-DI
- 04058863080383 FDA UDI
- 510(k) Number
- K112360 FDA UDI
- FDA Product Code
- DTZ FDA UDIDTR FDA UDIKFM FDA UDI
- GMDN Term
- Cardiopulmonary bypass system blood tubing set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4350 FDA UDI870.4240 FDA UDI870.4360 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
Yes
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
Dimensions & Sizes
- Size
- Total Volume — 600 Milliliter FDA UDI
Category: Cardiopulmonary bypass system blood tubing set
HLS Set by Maquet Cardiopulmonary AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiopulmonary bypass system blood tubing set.
- Perfusion Pack — LivaNova USA, Inc.
- Cardiovascular Procedure Kit — Terumo Cardiovascular Systems Corporation
- Perfusion Pack — LivaNova USA, Inc.
- Perfusion Pack — LivaNova USA, Inc.
- Cardiovascular Procedure Kit — Terumo Cardiovascular Systems Corporation
- Cardiovascular Procedure Kit — Terumo Cardiovascular Systems Corporation
- Cardiovascular Procedure Kit — Terumo Cardiovascular Systems Corporation
- Perfusion Pack — LivaNova USA, Inc.
Cleared under the same submission
K112360 also covers:
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
- Maquet Cardiopulmonary AG
Sources (1)
- FDA UDI 5e001841-a422-4a15-8f1f-bb6b0735a37d 36 fields · synced Jun 8, 2026