FDA UDI
In Commercial Distribution
🇺🇸 United States
Bard
DI: 03700506307067
·
Model: Bard
·
GRAPHIC CONTROLS ACQUISITION CORP
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Bard
- Primary DI
- 03700506307067
- Version / Model
- Bard
- Catalog Number
- IPC73041
- Company Name
- GRAPHIC CONTROLS ACQUISITION CORP
- Labeler DUNS
- 002111896
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-08-30
- Public Version
- 1
- Public Version Date
- 2019-09-09
- Public Version Status
- New
- Public Device Record Key
- ab1a91bc-63ff-4203-b9a6-29c5a03a5a8f
Device Description
CUSTOM CABLE-BARD/QUICK CONNECT
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | Cardiovascular | 870.2900 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36349 | Patient monitoring system module, electrocardiographic | A small unit dedicated to the detection, measurement, and recording of the electrical activity of the heart in the form of an electrocardiogram (ECG) obtained through cables/leads connected to the patient. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device or a connected module rack. The parent device operates as a mainframe computer displaying the ECG parameter/information measured and provided by this module. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03700506307067 | GS1 |
Customer Contacts
- Phone
- 800-669-6905
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K162768 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 158 Degrees Fahrenheit