Identity
- Trade Name
- Transpac™ FDA UDI
- Generic Name
- Invasive blood pressure transducer set FDA UDI
- Device Name
- Trifurcated Transpac™ IT Monitoring Kit w/03 ml Squeeze Flush Devices and Safeset™ Reservoir FDA UDI
- Model / Reference
- 460800451 FDA UDI
- Description
- Trifurcated Transpac™ IT Monitoring Kit w/03 ml Squeeze Flush Devices and Safeset™ Reservoir FDA UDI
Identifiers
- Catalog Number
- 460800451 FDA UDI
- Primary DI / UDI-DI
- 00887709047600 FDA UDI
- 510(k) Number
- K052828 FDA UDI
- FDA Product Code
- DRS FDA UDI
- GMDN Term
- Invasive blood pressure transducer set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2850 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Invasive blood pressure transducer set
Transpac™ by Icu Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Invasive blood pressure transducer set.
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- ArgoTrans™ — Merit Medical Systems, Inc. · Class II
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- Antmed — ShenZhen Antmed Co., Ltd · Class II
- BIOTRANS™ Pressure Monitoring Kits — BIOPTIMAL INTERNATIONAL PTE. LTD. · Class II
- Monitoring Kit — Argon Medical Devices, Inc. · Class II
- Merit Medical® — Merit Medical Systems, Inc. · Class II
Cleared under the same submission
K052828 also covers:
- ICU Medical — ICU MEDICAL, INC.
- ICU Medical — ICU MEDICAL, INC.
- ICU Medical — ICU MEDICAL, INC.
- ICU Medical — ICU MEDICAL, INC.
- ICU Medical — ICU MEDICAL, INC.
- ICU Medical — ICU MEDICAL, INC.
- ICU Medical — ICU MEDICAL, INC.
- ICU Medical — ICU MEDICAL, INC.
- ICU Medical — ICU MEDICAL, INC.
- ICU Medical — ICU MEDICAL, INC.
- ICU Medical — ICU MEDICAL, INC.
- ICU Medical — ICU MEDICAL, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Icu Medical, Inc.
Sources (1)
- FDA UDI ffef50bb-a45d-4218-a148-f5a8c9a83686 36 fields · synced May 30, 2026