Identity
- Trade Name
- 3-Spike Disposable Set FDA UDI
- Generic Name
- Heat-exchanging intravenous administration set FDA UDI
- Model / Reference
- 903-00006 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10896128002029 FDA UDI
- 510(k) Number
- K242735 FDA UDI
- FDA Product Code
- FRN FDA UDILGZ FDA UDI
- GMDN Term
- Heat-exchanging intravenous administration set 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
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
No
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
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Heat-exchanging intravenous administration set
3-Spike Disposable Set by Belmont Instrument Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Heat-exchanging intravenous administration set.
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Cleared under the same submission
K242735 also covers:
- 3-Spike Disposable Set (1 Piece) — Belmont Instrument Corp.
- 3.0 Liter Disposable Set — Belmont Instrument Corp.
- 3.0 Liter Reservoir (1 Piece) — Belmont Instrument Corp.
- 3.0 Liter Reservoir (6 Count) — Belmont Instrument Corp.
- Dual Patient Line — Belmont Instrument Corp.
- Dual Patient Line (1 Piece) — Belmont Instrument Corp.
- Patient Line Extension — Belmont Instrument Corp.
- Patient Line Extension (1 Piece) — Belmont Instrument Corp.
- Rapid Infuser RI-2, 120V, 1000ml/min — Belmont Instrument Corp.
- Rapid Infuser RI-2, 120V, 750 ml/min — Belmont Instrument Corp.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Belmont Instrument Corp.
Sources (1)
- FDA UDI 5457d56f-fc8f-4509-9abc-192030fb8a2d 33 fields · synced May 30, 2026