Identity
- Trade Name
- FL-9000 RESPIRATORY HUMIDIFIER USA FDA UDI
- Generic Name
- Heated respiratory humidifier FDA UDI
- Model / Reference
- FL9000U FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055788768081 FDA UDI
- 510(k) Number
- K161314 FDA UDI
- FDA Product Code
- BTT FDA UDI
- GMDN Term
- Heated respiratory humidifier FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5450 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
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: Heated respiratory humidifier
Fl-9000 Respiratory Humidifier Usa by Flexicare Medical Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Heated respiratory humidifier.
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Cleared under the same submission
K161314 also covers:
- Dual Heated Wire Humidifier Adapter — FLEXICARE MEDICAL LIMITED
- FL9000 — FLEXICARE MEDICAL LIMITED
- FL9000 — FLEXICARE MEDICAL LIMITED
- Humidifier Temperature Probe (1.5m) — FLEXICARE MEDICAL LIMITED
- Respiratory Humidifier Mounting Accessory C-Clamp Suitable For 19-4.0mm Pole — FLEXICARE MEDICAL LIMITED
- Respiratory Humidifier Mounting Accessory Pole Clamp Suitable For 30-50mm Pole — FLEXICARE MEDICAL LIMITED
- Respiratory Humidifier Mounting Accessory Rail Bracket — FLEXICARE MEDICAL LIMITED
- Respiratory Humidifier Mounting Accessory Wall Bracket — FLEXICARE MEDICAL LIMITED
- Respiratory Humidifier Mounting Accessory off Set Rail Bracket — FLEXICARE MEDICAL LIMITED
- Sing Heated Wire Humidifier Adapter — FLEXICARE MEDICAL LIMITED
- Water Bag Pole — FLEXICARE MEDICAL LIMITED
- Water Bag Pole Mounting Bracket — FLEXICARE MEDICAL LIMITED
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
- Flexicare Medical Limited
Sources (1)
- FDA UDI 0744412b-69c8-446c-9a5b-80c1b7dee269 33 fields · synced May 30, 2026