Identity
- Trade Name
- Bard FDA UDI
- Generic Name
- Patient monitoring system module, electrocardiographic FDA UDI
- Device Name
- CUSTOM CABLE-BARD/QUICK CONNECT FDA UDI
- Model / Reference
- Bard FDA UDI
- Description
- CUSTOM CABLE-BARD/QUICK CONNECT FDA UDI
Identifiers
- Catalog Number
- IPC73041 FDA UDI
- Primary DI / UDI-DI
- 03700506307067 FDA UDI
- 510(k) Number
- K162768 FDA UDI
- FDA Product Code
- DSA FDA UDI
- GMDN Term
- Patient monitoring system module, electrocardiographic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2900 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Patient monitoring system module, electrocardiographic
Bard by Graphic Controls Acquisition Corp — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K162768 also covers:
- Biosense — GRAPHIC CONTROLS ACQUISITION CORP
- Physio Control — GRAPHIC CONTROLS ACQUISITION CORP
- St Jude Medical — GRAPHIC CONTROLS ACQUISITION CORP
- INTEGRAL PROCESS Cables & Leadwires — NISSHA MEDICAL TECHNOLOGIES SAS
- INTEGRAL PROCESS Cables & Leadwires — NISSHA MEDICAL TECHNOLOGIES SAS
- INTEGRAL PROCESS Cables & Leadwires — NISSHA MEDICAL TECHNOLOGIES SAS
- INTEGRAL PROCESS Cables & Leadwires — NISSHA MEDICAL TECHNOLOGIES SAS
- INTEGRAL PROCESS Cables & Leadwires — NISSHA MEDICAL TECHNOLOGIES SAS
- INTEGRAL PROCESS Cables & Leadwires — NISSHA MEDICAL TECHNOLOGIES SAS
- INTEGRAL PROCESS Cables & Leadwires — NISSHA MEDICAL TECHNOLOGIES SAS
- INTEGRAL PROCESS Cables & Leadwires — NISSHA MEDICAL TECHNOLOGIES SAS
- INTEGRAL PROCESS Cables & Leadwires — NISSHA MEDICAL TECHNOLOGIES SAS
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
- Graphic Controls Acquisition Corp
Sources (1)
- FDA UDI ab1a91bc-63ff-4203-b9a6-29c5a03a5a8f 37 fields · synced Jun 8, 2026