Identity
- Trade Name
- Medline FDA UDI
- Generic Name
- Wound irrigation kit FDA UDI
- Device Name
- TRAY,IRRIGATION,BULBSYRINGE,60ML,CSR,PVP FDA UDI
- Model / Reference
- DYND20100 FDA UDI
- Description
- TRAY,IRRIGATION,BULBSYRINGE,60ML,CSR,PVP FDA UDI
Identifiers
- Catalog Number
- DYND20100 FDA UDI
- Primary DI / UDI-DI
- 10080196031672 FDA UDI
- FDA Product Code
- KYZ FDA UDI
- GMDN Term
- Wound irrigation kit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6960 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 60 Milliliter FDA UDI
Category: Wound irrigation kit
Medline by Medline Industries, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wound irrigation kit.
- Igloo Wound Irrigator — Bionix, LLC · Class I
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class I
- Stradis Medical, LLC. — STRADIS MEDICAL, LLC
- Medical Action Industries — MEDICAL ACTION INDUSTRIES INC. · Class I
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class I
- Stradis Medical, LLC. — STRADIS MEDICAL, LLC
- Igloo Wound Irrigator — Bionix, LLC · Class I
- Igloo Wound Irrigator — Bionix, LLC · 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
- Medline Industries, Inc.
Sources (1)
- FDA UDI c0599e46-5d2f-4428-9cc4-792a1459587a 36 fields · synced Jun 8, 2026