Identity
- Trade Name
- 3/16'' x 3/16'' Straight Connector FDA UDI
- Generic Name
- Low-pressure tubing connector, single-use, sterile FDA UDI
- Device Name
- This device is intended for use during cardiopulmonary bypass in conjunction with other medically approved devices and equipment that are utilized for this procedure. FDA UDI
- Model / Reference
- 1.7 FDA UDI
- Description
- This device is intended for use during cardiopulmonary bypass in conjunction with other medically approved devices and equipment that are utilized for this procedure. FDA UDI
Identifiers
- Catalog Number
- C-675 FDA UDI
- Primary DI / UDI-DI
- 36641670004476 FDA UDI
- 510(k) Number
- K833112 FDA UDI
- FDA Product Code
- DWF FDA UDI
- GMDN Term
- Low-pressure tubing connector, single-use, sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4210 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
No
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
Category: Low-pressure tubing connector, single-use, sterile
3/16'' x 3/16'' Straight Connector by Cardio Med Supplies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Low-pressure tubing connector, single-use, sterile.
- Busse Hospital Disposables — ROBERT BUSSE & CO., INC. · Class I
- MEDLINE INDUSTRIES, INC. — MEDLINE INDUSTRIES, INC. · Class II
- MEDLINE INDUSTRIES, INC. — MEDLINE INDUSTRIES, INC. · Class I
- Custom Healthcare Systems Inc. — Manus Medical, LLC · Class I
- Busse Hospital Disposables — ROBERT BUSSE & CO., INC. · Class I
- Busse Hospital Disposables — ROBERT BUSSE & CO., INC. · Class I
- 3/16'' Y Connector w/L.L. — Cardio Med Supplies, Inc. · Class II
- 3/8'' x 1/2'' x 1/2'' Y Connector w/L.L. — Cardio Med Supplies, Inc. · Class II
Cleared under the same submission
K833112 also covers:
- 1/2'' Y Connector w/L.L. — Cardio Med Supplies, Inc.
- 1/2'' x 1/2'' Straight Connector — Cardio Med Supplies, Inc.
- 1/2'' x 1/2'' Straight Connector w/L.L. — Cardio Med Supplies, Inc.
- 1/2'' x 3/8'' Reducer Connector — Cardio Med Supplies, Inc.
- 1/2'' x 3/8'' Reducer Connector w/L.L. — Cardio Med Supplies, Inc.
- 1/2'' x 3/8'' x 1/2'' Y Connector — Cardio Med Supplies, Inc.
- 1/2'' x 3/8'' x 3/8'' Y Connector — Cardio Med Supplies, Inc.
- 1/2'' x 3/8'' x 3/8'' Y Connector w/L.L. — Cardio Med Supplies, Inc.
- 1/2'' x 3/8'' x1/2'' Y Connector w/L.L. — Cardio Med Supplies, Inc.
- 1/4'' Tubing Adapter with Rotating Luer Lock — Cardio Med Supplies, Inc.
- 1/4'' Y Connector w/L.L. — Cardio Med Supplies, Inc.
- 1/4'' to I.V. Connector — Cardio Med Supplies, 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
- Cardio Med Supplies, Inc.
Sources (1)
- FDA UDI 379a782f-88f3-4ccb-83e0-c82748c5094b 35 fields · synced May 30, 2026