Identity
- Trade Name
- Medline FDA UDI
- Generic Name
- Oxygen administration tubing FDA UDI
- Device Name
- DBD-CO2 SAMPLING CANNULA,ADLT,STD,7'O2,7 FDA UDI
- Model / Reference
- HCS4571 FDA UDI
- Description
- DBD-CO2 SAMPLING CANNULA,ADLT,STD,7'O2,7 FDA UDI
Identifiers
- Catalog Number
- HCS4571 FDA UDI
- Primary DI / UDI-DI
- 10888277420601 FDA UDI
- 510(k) Number
- K063813 FDA UDI
- FDA Product Code
- CCK FDA UDI
- GMDN Term
- Oxygen administration tubing FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.1400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Oxygen administration tubing
Medline by Medline Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Oxygen administration tubing.
- STRAIGHT CONNECTOR, DISPOSABLE (ID:22mm, OD:15mm) — BESMED HEALTH BUSINESS CORP. · Class I
- PEGASUS — Pegasus Research Corp. · Class I
- 9362 — Oy Fluorplast Ab · Class IIa
- Y-Connector with two 7’ bonded green tubes with ribbed fittings — SALTER LABS · Class IIa
- HUDSON RCI — TELEFLEX INCORPORATED · Class I
- AirLife™ — VYAIRE MEDICAL, INC. · Class I
- Comfort Soft Plus CO2 Sampling Nasal Cannula — WESTMED, INC. · Class II
- Resp-O2 Oxygen Supply Tubing — Dynarex Corp. · Class I
Cleared under the same submission
K063813 also covers:
- Curaplex — BOUND TREE MEDICAL, LLC
- Curaplex — BOUND TREE MEDICAL, LLC
- Curaplex — BOUND TREE MEDICAL, LLC
- Curaplex — BOUND TREE MEDICAL, LLC
- Curaplex — BOUND TREE MEDICAL, LLC
- Curaplex — BOUND TREE MEDICAL, LLC
- Curaplex — BOUND TREE MEDICAL, LLC
- Curaplex — BOUND TREE MEDICAL, LLC
- Curaplex — BOUND TREE MEDICAL, LLC
- Curaplex — BOUND TREE MEDICAL, LLC
- Curaplex — BOUND TREE MEDICAL, LLC
- Curaplex — BOUND TREE MEDICAL, LLC
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
- Medline Industries, Inc.
Sources (1)
- FDA UDI cede0c7c-440e-41c4-bd11-b9f2c04926c9 36 fields · synced Jun 6, 2026