Identity
- Trade Name
- HMG IV extension sets- CVM100B FDA UDI
- Generic Name
- Intravenous administration tubing extension set FDA UDI
- Device Name
- 7" IV Extension Set, micro bore with bonded needlefree valve FDA UDI
- Model / Reference
- CVM100B FDA UDI
- Description
- 7" IV Extension Set, micro bore with bonded needlefree valve FDA UDI
Identifiers
- Primary DI / UDI-DI
- 60850048235078 FDA UDI
- 510(k) Number
- K150513 FDA UDI
- FDA Product Code
- FPA FDA UDI
- GMDN Term
- Intravenous administration tubing extension set 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: Intravenous administration tubing extension set
HMG IV extension sets- CVM100B 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 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
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 7a85fc21-8a72-47f7-bf76-28e399147a96 34 fields · synced May 30, 2026