FDA UDI
In Commercial Distribution
🇺🇸 United States
ICU Medical
DI: 00840619045166
·
Model: 46063-69
·
ICU MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- ICU Medical
- Primary DI
- 00840619045166
- Version / Model
- 46063-69
- Catalog Number
- 460630469
- Company Name
- ICU MEDICAL, INC.
- Labeler DUNS
- 118380146
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-08-29
- Public Version
- 1
- Public Version Date
- 2021-09-06
- Public Version Status
- New
- Public Device Record Key
- 93374f00-28e8-41a5-a42e-f9cf0cf1e1ab
Device Description
Transpac™-4 KIT WITH 03ML FLUSH DEVICE
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
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DRS | Transducer, blood-pressure, extravascular | Cardiovascular | 870.2850 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45760 | In-line arterial blood sampling set | A collection of sterile devices designed to obtain an in-line arterial blood specimen while maintaining a closed system. It is a haemodynamic pressure monitoring and blood gas sampling device, typically designed for use with disposable/reusable pressure transducers, intended to connect to a central line/arterial catheter from which the blood specimen is obtained. Heparinized blood may be reinfused into the patient via the device to reduce fluid loss. This is a single-patient device that may be used short term (single-use) before being discarded. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10840619045163 | GS1 | CS | 20 | In Commercial Distribution | |
| Primary | 00840619045166 | GS1 |
Customer Contacts
- Phone
- +1(866)829-9025
- [email protected]