ICU Medical, Inc.
- Primary DI
- 10887709176000
- Brand
- ICU Medical, Inc.
- Company
- ICU MEDICAL, INC.
- Model
- 46117-44
- Device description
- GTIN for 46117-44, 1/EA
- Published
- 2026-02-16
- 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 |
|---|
| DRS | Transducer, blood-pressure, extravascular |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| DRS | Transducer, Blood-Pressure, Extravascular | Cardiovascular | 2 |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|
| K061573 | 000 | TRANSPAC III DISPOSABLE STRAIGHT PRESSURE TRANSDUCER AND KIT | Hospira, Inc. | 2006-09-19 | DRS |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 10887709176000 | Package | GS1 | 20 | In Commercial Distribution |
| 00887709176003 | Primary | GS1 | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Invasive blood pressure transducer set | A collection of devices that includes tubing, a pressure transducer(s), and other items [e.g., connectors, stopcock(s), clamps and filters] intended to be used for an invasive blood pressure measurement. This set will typically connect directly to the applied invasive catheter and the transducer will provide the electrical signals for display by a patient monitoring system. This device will have physical characteristics appropriate for preserving, to the extent possible, the waveform and fidelity of the measured pressure. This is a single-use device. |
Regulatory Flags
- DUNS number
- 118380146
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 10887709175980 | ICU Medical, Inc. | ICU MEDICAL, INC. | DRS | 2026-02-16 |
| 10887709175997 | ICU Medical, Inc. | ICU MEDICAL, INC. | DRS | 2026-02-16 |
| 10887709128092 | ICU Medical, Inc. | ICU MEDICAL, INC. | DRS | 2025-04-08 |
| 08886483503854 | ACCUTRANS™ Disposable Pressure Monitoring System | BIOPTIMAL INTERNATIONAL PTE. LTD. | DRS | 2025-01-22 |
| 00690103201079 | Acumen IQ | Edwards Lifesciences LLC | DRS | 2024-09-23 |
| 50690103200930 | Acumen IQ | Edwards Lifesciences LLC | DRS | 2024-08-27 |
| 50690103200954 | Acumen IQ | Edwards Lifesciences LLC | DRS | 2024-08-27 |
| 50690103200978 | ACUMEN IQ SENSOR | Edwards Lifesciences LLC | DRS | 2024-08-27 |
| 00690103201093 | Acumen IQ | Edwards Lifesciences LLC | DRS | 2024-08-27 |
| 00690103201109 | ACUMEN IQ SENSOR | Edwards Lifesciences LLC | DRS | 2024-08-27 |
| 00840619028152 | Transpac™/Transtar™ | ICU MEDICAL, INC. | DRS | 2024-08-20 |
| 00840619037185 | Transpac™/Transtar™ | ICU MEDICAL, INC. | DRS | 2024-08-20 |
| 00840619045104 | Transpac™/Transtar™ | ICU MEDICAL, INC. | DRS | 2024-08-20 |
| 00840619065102 | Transpac™/Transtar™ | ICU MEDICAL, INC. | DRS | 2024-08-20 |
| 00840619067212 | Transpac™/Transtar™ | ICU MEDICAL, INC. | DRS | 2024-08-20 |
| 00840619097257 | Transpac™/Transtar™ | ICU MEDICAL, INC. | DRS | 2024-08-20 |
| 00887709044838 | Transpac™/Transtar™ | ICU MEDICAL, INC. | DRS | 2024-08-20 |
| 00887709045255 | Transpac™/Transtar™ | ICU MEDICAL, INC. | DRS | 2024-08-20 |
| 00887709045293 | Transpac™/Transtar™ | ICU MEDICAL, INC. | DRS | 2024-08-20 |
| 00887709045460 | Transpac™/Transtar™ | ICU MEDICAL, INC. | DRS | 2024-08-20 |
| 00887709070684 | Transpac™/Transtar™ | ICU MEDICAL, INC. | DRS | 2024-08-20 |
| 00887709089280 | Transpac™/Transtar™ | ICU MEDICAL, INC. | DRS | 2024-08-20 |
| 00887709121416 | Transpac™/Transtar™ | ICU MEDICAL, INC. | DRS | 2024-08-20 |
| 00887709127494 | Transpac™/Transtar™ | ICU MEDICAL, INC. | DRS | 2024-08-20 |
| 00887709127500 | Transpac™/Transtar™ | ICU MEDICAL, INC. | DRS | 2024-08-20 |
| 00887709127517 | Transpac™/Transtar™ | ICU MEDICAL, INC. | DRS | 2024-08-20 |
| 00887709127524 | Transpac™/Transtar™ | ICU MEDICAL, INC. | DRS | 2024-08-20 |
| 00887709127531 | Transpac™/Transtar™ | ICU MEDICAL, INC. | DRS | 2024-08-20 |
| 00887709127548 | Transpac™/Transtar™ | ICU MEDICAL, INC. | DRS | 2024-08-20 |
| 00887709127555 | Transpac™/Transtar™ | ICU MEDICAL, INC. | DRS | 2024-08-20 |