Identity
- Trade Name
- ARROW FDA UDI
- Generic Name
- Pneumothorax catheter insertion set FDA UDI
- Device Name
- Pneumothorax Kit FDA UDI
- Model / Reference
- IPN034176 FDA UDI
- Description
- Pneumothorax Kit FDA UDI
Identifiers
- Catalog Number
- ASK-01500-JCM FDA UDI
- Primary DI / UDI-DI
- 20801902053279 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
Similar devices
Also classified as Pneumothorax catheter insertion set.
- Curaplex — BOUND TREE MEDICAL, LLC · Class I
- TMM-CT-SO (Tactical Medical Module-Chest Tube-Special Operations) — Altitude Technologies Inc. · Class I
- 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
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 4a637fad-d104-463a-aa33-68dd0774300f 37 fields · synced Jun 8, 2026