FDA UDI
In Commercial Distribution
🇺🇸 United States
CARDINAL HEALTH
DI: 10197106398050
·
Model: 34-4536C
·
Cardinal Health 200, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- CARDINAL HEALTH
- Primary DI
- 10197106398050
- Version / Model
- 34-4536C
- Catalog Number
- 34-4536C
- Company Name
- Cardinal Health 200, LLC
- Labeler DUNS
- 961027315
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-11-09
- Public Version
- 1
- Public Version Date
- 2023-11-17
- Public Version Status
- New
- Public Device Record Key
- 642f1f5f-5f12-4fad-bdaf-2e8df4d943cb
Device Description
EPIDURAL TRAY
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OEG | Autoantibodies, skin (bullous pemphigoid 180 and bullous pemphigoid 230 | Immunology | 866.5660 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64348 | Epidural/intrathecal anaesthesia set, medicated | A dual-purpose collection of devices intended for the administration of an analgesic or anaesthetic agent to the intrathecal space and to the epidural space for the management of pain. It includes the pharmaceutical anaesthetic agent, and both a spinal needle and an epidural needle with additional devices utilized for the procedure (e.g., dressings, syringe), and may include an epidural catheter for continuous-administration. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50197106398058 | GS1 | CASE | 37 | In Commercial Distribution | |
| Primary | 10197106398050 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- High: 40 Degrees Celsius