Identity
- Trade Name
- Fisher & Paykel Healthcare FDA UDI
- Generic Name
- Pulmonary resuscitator, pneumatic, reusable FDA UDI
- Device Name
- Neopuff™ Infant T-Piece Resuscitator IW Module FDA UDI
- Model / Reference
- 900IW130E FDA UDI
- Description
- Neopuff™ Infant T-Piece Resuscitator IW Module FDA UDI
Identifiers
- Catalog Number
- 900IW130E FDA UDI
- Primary DI / UDI-DI
- 09420012409003 FDA UDI
- 510(k) Number
- K971695 FDA UDI
- FDA Product Code
- FMT FDA UDI
- GMDN Term
- Pulmonary resuscitator, pneumatic, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5130 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Pulmonary resuscitator, pneumatic, reusable
Fisher & Paykel Healthcare by Fisher & Paykel Healthcare, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pulmonary resuscitator, pneumatic, reusable.
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- Pneupac — ICU MEDICAL, INC. · Class II
- CAREvent ALS — O-Two Medical Technologies Inc
- Life Support Products — Allied Medical LLC · Class II
- Puffin Lite Infant Resuscitator — INTERNATIONAL BIOMEDICAL, LTD. · Class II
- SILICONE INFANT 280ML RESUSCITATOR W/ POP-OFF 40CM H2O — BESMED HEALTH BUSINESS CORP. · Class II
Cleared under the same submission
K971695 also covers:
- FISHER & PAYKEL HEALTHCARE — FISHER & PAYKEL HEALTHCARE, INC.
- Fisher & Paykel Healthcare — FISHER & PAYKEL HEALTHCARE, INC.
- Fisher & Paykel Healthcare — FISHER & PAYKEL HEALTHCARE, INC.
- Fisher & Paykel Healthcare — FISHER & PAYKEL HEALTHCARE, INC.
- Fisher & Paykel Healthcare — FISHER & PAYKEL HEALTHCARE, INC.
- Fisher & Paykel Healthcare — FISHER & PAYKEL HEALTHCARE, INC.
- Fisher & Paykel Healthcare — FISHER & PAYKEL HEALTHCARE, INC.
- Fisher & Paykel Healthcare — FISHER & PAYKEL HEALTHCARE, INC.
- Fisher & Paykel Healthcare — FISHER & PAYKEL HEALTHCARE, INC.
- Fisher & Paykel Healthcare — FISHER & PAYKEL HEALTHCARE, INC.
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
- Fisher & Paykel Healthcare, Inc.
Sources (1)
- FDA UDI bee355db-0382-496a-ab30-53852cafff71 36 fields · synced May 30, 2026