FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Kendall
DI: 20884527002822
·
Model: 50000095
·
Cardinal Health, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Kendall
- Primary DI
- 20884527002822
- Version / Model
- 50000095
- Catalog Number
- 50000095
- Company Name
- Cardinal Health, Inc.
- Labeler DUNS
- 080935429
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 8
- Public Version Date
- 2023-07-03
- Public Version Status
- Update
- Public Device Record Key
- 76066bda-c3e1-4e04-9992-908641ff7695
- Distribution End Date
- 2023-07-01
Device Description
Fetal Spiral Electrode Attachment Pad,Large
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HGP | ELECTRODE, CIRCULAR (SPIRAL), SCALP AND APPLICATOR | Obstetrics/Gynecology | 884.2675 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35035 | Electrocardiographic electrode, single-use | A non-sterile, noninvasive electrical conductor designed to conduct electrical signals, generated by a patient's heart, from the skin surface to an electrocardiograph (ECG) monitoring device, via an ECG lead wire (not included). It is typically a disk-like electrode that is affixed to the skin with a special adhesive, adhesive tape, or suction mechanism; a conductive gel may be pre-applied and it may include a skin cleaning wipe to assist electrical connection. Electrocardiography is usually performed using a set of electrodes (e.g., 10) connected to appropriate leads and cables. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10884527002825 | GS1 | CASE | 50 | Not in Commercial Distribution | 2023-07-01 |
| Primary | 20884527002822 | GS1 |
Customer Contacts
- Phone
- +1(508)261-8000
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 1.875 | Inch | |
| Length | 3.75 | Inch |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- No;