Identity
- Trade Name
- HMG IV Administration Set FDA UDI
- Generic Name
- Basic intravenous administration set, noninvasive FDA UDI
- Device Name
- 100” (254cm) Primary Administration Set With Universal Spike Drip Chamber with Needle Free Y-site FDA UDI
- Model / Reference
- FCA1002 FDA UDI
- Description
- 100” (254cm) Primary Administration Set With Universal Spike Drip Chamber with Needle Free Y-site FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10850048235141 FDA UDI
- 510(k) Number
- K150513 FDA UDI
- FDA Product Code
- FPA FDA UDI
- GMDN Term
- Basic intravenous administration set, noninvasive FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5440 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Basic intravenous administration set, noninvasive
HMG IV Administration Set by Hartman Medical Group, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K150513 also covers:
- Curaplex — BOUND TREE MEDICAL, LLC
- HMG IV Administration Set — Hartman Medical Group,LLC
- HMG IV Extension Set CV100B — Hartman Medical Group,LLC
- HMG IV extension Set-CV200B — Hartman Medical Group,LLC
- HMG IV extension Sets CV100B — Hartman Medical Group,LLC
- HMG IV extension Sets CV100R — Hartman Medical Group,LLC
- HMG IV extension Sets CV100R — Hartman Medical Group,LLC
- HMG IV extension Sets CV100R — Hartman Medical Group,LLC
- HMG IV extension Sets CV200B — Hartman Medical Group,LLC
- HMG IV extension Sets CV300B — Hartman Medical Group,LLC
- HMG IV extension set CV100B — Hartman Medical Group,LLC
- HMG IV extension set CV200B — Hartman Medical Group,LLC
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
- Hartman Medical Group, LLC
Sources (1)
- FDA UDI 984e3894-e0c4-4161-92da-35bad9529900 34 fields · synced May 29, 2026