CARDINAL HEALTH
- Primary DI
- 50195594464231
- Brand
- CARDINAL HEALTH
- Company
- Cardinal Health 200, LLC
- Model
- SMA11CSJH1
- Catalog number
- SMA11CSJH1
- Device description
- C BIRTH PK
- Published
- 2021-11-23
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes
| Code | Name |
|---|
| OHF | Culdocentesis kit |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| OHF | Culdocentesis Kit | Obstetrics/Gynecology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 50195594464231 | Package | GS1 | 5 | In Commercial Distribution |
| 10195594464233 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|
| 50195594464231 | 50195594464231 |
| 10195594464233 | 10195594464233 |
GMDN Terms
| Term | Definition |
|---|
| Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use | A collection of various sterile surgical instruments, dressings/drapes, and materials intended to be used during obstetrical/gynaecological surgery. The kit may be referred to as a procedure pack and is typically comprised of devices that individually are not dedicated to a specific type of obstetrical/gynaecological surgical procedure, but are often supplied together to perform a specific type of obstetrical/gynaecological procedure; it does not contain pharmaceuticals. This is a single-use device. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Storage Environment Temperature | 15 Degrees Celsius | 30 Degrees Celsius | |
Regulatory Flags
- DUNS number
- 961027315
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- false
Other Devices From This Company
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 50197106191796 | CARDINAL HEALTH | Cardinal Health 200, LLC | OHF | 2023-06-12 |
| 50195594673855 | CARDINAL HEALTH | Cardinal Health 200, LLC | OHF | 2022-05-13 |