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Cirrus2 Nebuliser, Paediatric Intersurgical Ecolite Mask Kit With Tube, 2.1m
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- CIRRUS2 NEBULISER, PAEDIATRIC INTERSURGICAL ECOLITE MASK KIT WITH TUBE, 2.1M FDA UDI
- Generic Name
- Nebulizing system delivery set, single-use FDA UDI
- Device Name
- CIRRUS2 NEBULISER, PAEDIATRIC INTERSURGICAL ECOLITE MASK KIT WITH TUBE, 2.1M FDA UDI
- Model / Reference
- 1454015 FDA UDI
- Description
- CIRRUS2 NEBULISER, PAEDIATRIC INTERSURGICAL ECOLITE MASK KIT WITH TUBE, 2.1M FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05030267104987 FDA UDI
- 510(k) Number
- K911422 FDA UDI
- FDA Product Code
- CAF FDA UDI
- GMDN Term
- Nebulizing system delivery set, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5630 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Yes
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: Nebulizing system delivery set, single-use
Cirrus2 Nebuliser, Paediatric Intersurgical Ecolite Mask Kit With Tube, 2.1m by Intersurgical Incorporated — Class II — FDA UDI — listed in FDA GUDID
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Also classified as Nebulizing system delivery set, single-use.
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Cleared under the same submission
K911422 also covers:
- CIRRUS 2 NEBULISER — Intersurgical Incorporated
- CIRRUS2 NEBULISER 18M WITH TUBE, 1.8M — Intersurgical Incorporated
- CIRRUS2 NEBULISER MOUTHPIECE KIT WITH TUBE, 2.1M — Intersurgical Incorporated
- CIRRUS2 NEBULISER MOUTHPIECE KIT WITH TUBE, 2.1M, SINGLE PATIENT USE — Intersurgical Incorporated
- CIRRUS2 NEBULISER, ADULT, INTERSURGICAL ECOLITE MASK KIT AND TUBE, 2.1M — Intersurgical Incorporated
- CIRRUS2 NEBULISER, ADULT, INTERSURGICAL ECOLITE MASK KIT WITH TUBE, 2.1M — Intersurgical Incorporated
- CIRRUS2 NEBULISER, ADULT, INTERSURGICAL ECOLITE MASK KIT WITH TUBE, 2.1M, SINGLE — Intersurgical Incorporated
- CIRRUS2 NEBULISER, PAEDIATRIC INTERSURGICAL ECOLITE MASK KIT AND TUBE, 2.1M — Intersurgical Incorporated
- CIRRUS2 NEBULISER, PAEDIATRIC, INTERSURGICAL ECOLITE MASK KIT WITH TUBE 2.1M — Intersurgical Incorporated
- CIRRUS2 NEBULISER, SINGLE PATIENT USE — Intersurgical Incorporated
- CIRRUS2 NEBULISER, UNIVERSAL MOUTHPIECE T-KIT WITH TUBE, 1.8M — Intersurgical Incorporated
- CIRRUS™2 NEBULISER MOUTHPIECE KIT AND TUBE WITH UNIVERSAL CONNECTOR, 2.1M — Intersurgical Incorporated
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
- Intersurgical Incorporated
Sources (1)
- FDA UDI 03ec2e27-fd2e-44a1-bb46-571a0824ff8e 35 fields · synced May 29, 2026