Identity
- Trade Name
- Fisher & Paykel Healthcare FDA UDI
- Generic Name
- Inspiratory/expiratory limb respiratory tubing, reusable FDA UDI
- Device Name
- Reusable breathing tubing 10mm x 0.3m FDA UDI
- Model / Reference
- 900MR017 FDA UDI
- Description
- Reusable breathing tubing 10mm x 0.3m FDA UDI
Identifiers
- Catalog Number
- 900MR017 FDA UDI
- Primary DI / UDI-DI
- 09420012401649 FDA UDI
- FDA Product Code
- BZO FDA UDI
- GMDN Term
- Inspiratory/expiratory limb respiratory tubing, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5975 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Inspiratory/expiratory limb respiratory tubing, reusable
Fisher & Paykel Healthcare by Fisher & Paykel Healthcare, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- CPAP Kit — SUNSET HEALTHCARE SOLUTIONS, Inc.
- CPAP Tubing — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Fisher & Paykel Healthcare, Inc.
Sources (1)
- FDA UDI 7a928d1f-aca5-4c71-b884-af878ac53a3d 35 fields · synced Jun 8, 2026