Identity
- Trade Name
- ARROW FDA UDI
- Generic Name
- Elastomeric infusion pump kit FDA UDI
- Device Name
- AF 550 X 5ML/H FH STD C,4"IN FDA UDI
- Model / Reference
- IPN914404 FDA UDI
- Description
- AF 550 X 5ML/H FH STD C,4"IN FDA UDI
Identifiers
- Catalog Number
- MT5060XLSK2-CP FDA UDI
- Primary DI / UDI-DI
- 14026704647641 FDA UDI
- 510(k) Number
- K090300 FDA UDI
- FDA Product Code
- MEB FDA UDI
- GMDN Term
- Elastomeric infusion pump kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5725 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
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: Elastomeric infusion pump kit
Arrow by Teleflex Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Elastomeric infusion pump kit.
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- ACTion Fuser Pump, 650ml, 5-15 ml/hrDual 140mm caut-to-size catheter — Ambu A/S · Class II
- AVANOS — Avanos Medical, Inc. · Class II
- ACTion Block Pump, 400ml, 1-6 ml/hr — Ambu A/S · Class II
- Halyard — Avanos Medical, Inc. · Class II
- Catheter Set, 190mm Cut-to Size, 9" Introducer + FlowSplitter — Ambu A/S · Class II
Cleared under the same submission
K090300 also covers:
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- LMA — TELEFLEX INCORPORATED
- LMA — TELEFLEX INCORPORATED
- LMA — TELEFLEX INCORPORATED
- LMA — TELEFLEX INCORPORATED
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Teleflex Incorporated
Sources (1)
- FDA UDI a1a9ebcd-a434-4bf6-8cc4-2471d1110c46 36 fields · synced Jun 8, 2026