Identity
- Trade Name
- Platypus® AV Fistula Needle Guard EUDAMEDFDA UDI
- Generic Name
- Needle guard FDA UDI
- Device Name
- Needle Guard EUDAMEDPlatypus® is intended for use in the prevention of accidental needle stick injuries upon completion of hemodialysis and apheresis procedures; Platypus® has been designed to allow the winged needle assembly to be pulled into the Platypus® and once fully engaged, the winged needle assembly is locked in, thus shielding and locking the needle and preventing needle exposure; Platypus® is supplied bulk, non-sterile. FDA UDI
- Model / Reference
- A100360 EUDAMEDFDA UDI
- Description
- Platypus® is intended for use in the prevention of accidental needle stick injuries upon completion of hemodialysis and apheresis procedures; Platypus® has been designed to allow the winged needle assembly to be pulled into the Platypus® and once fully engaged, the winged needle assembly is locked in, thus shielding and locking the needle and preventing needle exposure; Platypus® is supplied bulk, non-sterile. FDA UDI
Identifiers
- Catalog Number
- A100360 FDA UDI
- Primary DI / UDI-DI
- 19555240405293 EUDAMED19555240400168 FDA UDI
- Basic UDI-DI
- 955524040NGNSHU EUDAMED
- 510(k) Number
- K991404 FDA UDI
- FDA Product Code
- FMI FDA UDI
- EMDN Code
- A018001 NEEDLE CAPS EUDAMED
- GMDN Term
- Needle guard FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5570 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Platypus® AV Fistula Needle Guard by Itl Asia Pacific Sdn. Bhd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 955524040NGNSHU | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- ITL Asia Pacific Sdn. Bhd.
- EUDAMED SRN
- MY-MF-000001570
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 7fb94098-bbfa-4175-9c2c-bc23f25823a1 61 fields · synced Jun 20, 2026
- FDA UDI 7ed86615-92d4-4db8-8ab7-8c92ad4ad2b7 37 fields · synced May 29, 2026