FDA UDI
In Commercial Distribution
🇺🇸 United States
CARDINAL HEALTH
DI: 10198956308428
·
Model: SAN32EMMU8
·
Cardinal Health 200, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- CARDINAL HEALTH
- Primary DI
- 10198956308428
- Version / Model
- SAN32EMMU8
- Catalog Number
- SAN32EMMU8
- Company Name
- Cardinal Health 200, LLC
- Labeler DUNS
- 961027315
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-01-23
- Public Version
- 1
- Public Version Date
- 2026-02-02
- Public Version Status
- New
- Public Device Record Key
- d20ffb6c-b2a3-494c-be50-59ed5fcf933f
Device Description
EMBOLISM PACK
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 |
|---|---|---|---|---|
| OEZ | Cardiovascular procedure kit | Cardiovascular | 870.1200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64358 | Cardiovascular embolization implantation kit | A collection of dedicated instruments intended to be used for the implantation of an embolization implant (implant not included). It typically includes devices for arterial access (e.g., needle, introducer, guidewires) and devices to assist introduction and positioning of the implant (e.g., catheter). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50198956308426 | GS1 | CASE | 3 | In Commercial Distribution | |
| Primary | 10198956308428 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius