Identity
- Trade Name
- Remunity FDA UDI
- Generic Name
- Ambulatory non-insulin infusion pump, electronic FDA UDI
- Device Name
- DKPI-11038-001 (Training Kit) consists of a package containing the following: - Charger Assembly x1 - Dual USB Adapter x 1 - USB Cable x1 - Battery x2 FDA UDI
- Model / Reference
- DKPI-11038-001 FDA UDI
- Description
- DKPI-11038-001 (Training Kit) consists of a package containing the following: - Charger Assembly x1 - Dual USB Adapter x 1 - USB Cable x1 - Battery x2 FDA UDI
Identifiers
- Catalog Number
- DKPI-11038-001 FDA UDI
- Primary DI / UDI-DI
- 00850017421042 FDA UDI
- FDA Product Code
- QJY FDA UDI
- GMDN Term
- Ambulatory non-insulin infusion pump, electronic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5725 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Ambulatory non-insulin infusion pump, electronic
Remunity by United Therapeutics Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Ambulatory non-insulin infusion pump, electronic.
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- WalkMed® — WalkMed Technologies, LLC · Class II
- ambIT — Summit Medical Products, Inc. · Class II
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
- United Therapeutics Corporation
Sources (1)
- FDA UDI 737e1301-a54d-4099-b6bd-21897f567a30 36 fields · synced Jun 8, 2026