Identity
- Trade Name
- ARROW FDA UDI
- Generic Name
- Pneumothorax catheter insertion set FDA UDI
- Device Name
- Pneumothorax Kit FDA UDI
- Model / Reference
- IPN033839 FDA UDI
- Description
- Pneumothorax Kit FDA UDI
Identifiers
- Catalog Number
- AK-01500 FDA UDI
- Primary DI / UDI-DI
- 50801902004807 FDA UDI
- 510(k) Number
- K904021 FDA UDI
- FDA Product Code
- JDC FDA UDI
- GMDN Term
- Pneumothorax catheter insertion set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3150 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
Yes
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
Yes
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
Category: Pneumothorax catheter insertion set
Arrow by Teleflex Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Pneumothorax catheter insertion set.
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- Rocket — Rocket Medical Plc
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- Thora-Vent Thoracic Vent — Uresil Corp. · Class II
- H&H Chest Tube Insertion Kit — H & H Medical Corporation
- NAR — NORTH AMERICAN RESCUE, LLC. · Class I
- Master — Dongguan Maisite Medical Instruments Co., Ltd. · Class II
Cleared under the same submission
K904021 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
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — 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 7e4e681b-cab9-4516-b7bf-f915f4b71b03 37 fields · synced May 30, 2026