Identity
- Trade Name
- ARROW FDA UDI
- Generic Name
- Pneumothorax catheter insertion set FDA UDI
- Device Name
- Arrow-Clarke(TM) Pleura-Seal(R) Thoracentesis Kit FDA UDI
- Model / Reference
- IPN032616 FDA UDI
- Description
- Arrow-Clarke(TM) Pleura-Seal(R) Thoracentesis Kit FDA UDI
Identifiers
- Catalog Number
- AK-01000-J FDA UDI
- Primary DI / UDI-DI
- 00801902097965 FDA UDI
- 510(k) Number
- K870572 FDA UDI
- FDA Product Code
- JOL FDA UDI
- GMDN Term
- Pneumothorax catheter insertion set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6740 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
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
Category: Pneumothorax catheter insertion set
Arrow by Teleflex Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pneumothorax catheter insertion set.
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- Rocket — Rocket Medical Plc
- Rocket — Rocket Medical Plc
- 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
K870572 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 e0e80f44-3b7b-4438-b0c4-f1fe2ef7d3fa 36 fields · synced May 30, 2026