Identity
- Trade Name
- Dialysis Safety Syringe w/Needle FDA UDI
- Generic Name
- Haemodialysis needle FDA UDI
- Model / Reference
- 6932 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00616784693224 FDA UDI
- 510(k) Number
- K052445 FDA UDI
- FDA Product Code
- FMI FDA UDI
- GMDN Term
- Haemodialysis needle FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5570 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Category: Haemodialysis needle
Dialysis Safety Syringe w/Needle by Dynarex Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Haemodialysis needle.
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- JMS SYSLOC MINI AVF NEEDLE SET — JMS SINGAPORE PTE LTD · Class II
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- JMS HARMONY A.V.FISTULA NEEDLE SET — JMS SINGAPORE PTE LTD · Class II
Cleared under the same submission
K052445 also covers:
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
- Dynarex Corp.
Sources (1)
- FDA UDI f5558215-948b-4bfb-8d04-bded67c0fb2d 33 fields · synced May 30, 2026