Identity
- Trade Name
- Flow Control Tubing FDA UDI
- Generic Name
- Mechanical infusion pump administration set FDA UDI
- Model / Reference
- FCT 10mL/4h FDA UDI
Identifiers
- Catalog Number
- FCT10-4h FDA UDI
- Primary DI / UDI-DI
- 09350902000549 FDA UDI
- 510(k) Number
- K910007 FDA UDI
- FDA Product Code
- FRN FDA UDI
- GMDN Term
- Mechanical infusion pump 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
No
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
No
FDA UDI
Category: Mechanical infusion pump administration set
Flow Control Tubing by Go Medical Industries Pty. Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K910007 also covers:
- Flow Control Tubing — GO MEDICAL INDUSTRIES PTY. LTD.
- Flow Control Tubing — GO MEDICAL INDUSTRIES PTY. LTD.
- Flow Control Tubing — GO MEDICAL INDUSTRIES PTY. LTD.
- Flow Control Tubing — GO MEDICAL INDUSTRIES PTY. LTD.
- Flow Control Tubing — GO MEDICAL INDUSTRIES PTY. LTD.
- Flow Control Tubing — GO MEDICAL INDUSTRIES PTY. LTD.
- Flow Control Tubing — GO MEDICAL INDUSTRIES PTY. LTD.
- Flow Control Tubing — GO MEDICAL INDUSTRIES PTY. LTD.
- Flow Control Tubing — GO MEDICAL INDUSTRIES PTY. LTD.
- Flow Control Tubing — GO MEDICAL INDUSTRIES PTY. LTD.
- Flow Control Tubing — GO MEDICAL INDUSTRIES PTY. LTD.
- Flow Control Tubing — GO MEDICAL INDUSTRIES PTY. LTD.
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
- Go Medical Industries Pty. Ltd.
Sources (1)
- FDA UDI 055548e4-34df-4304-8f2a-6835c3bd9642 34 fields · synced Jun 1, 2026