Identity
- Trade Name
- SuctionShield FDA UDI
- Generic Name
- Airway suction catheter FDA UDI
- Device Name
- The holster device provides safe and convenient storage of the Yankauer Suction Tip between suctions of the individual patient. It is designed to avoid contamination of the individual patient's suction tip by preventing contact of the tip with any surface other than the patient's own disposable holster or cross contamination of other patients and healthcare personnel. The device is a disposable, plastic, wide mouthed receptacle, intended to be attached to the patient's bed rail. FDA UDI
- Model / Reference
- PSC5300 FDA UDI
- Description
- The holster device provides safe and convenient storage of the Yankauer Suction Tip between suctions of the individual patient. It is designed to avoid contamination of the individual patient's suction tip by preventing contact of the tip with any surface other than the patient's own disposable holster or cross contamination of other patients and healthcare personnel. The device is a disposable, plastic, wide mouthed receptacle, intended to be attached to the patient's bed rail. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00861283000312 FDA UDI
- FDA Product Code
- JOL FDA UDI
- GMDN Term
- Airway suction catheter 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Airway suction catheter
SuctionShield by Patient Shield Concepts Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Airway suction catheter.
- AirLife™ — Airlife, Inc. · Class I
- Closed Suction Catheters — Ningbo Xinwell Medical Technology Co., Ltd. · Class I
- Closed Suction Catheters — Ningbo Xinwell Medical Technology Co., Ltd. · Class I
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- Little Sucker Standard TP — Neotech Products LLC · Class II
- Closed Suction Catheters — Ningbo Xinwell Medical Technology Co., Ltd. · Class I
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
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 |
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Manufacturer
- Manufacturer
- Patient Shield Concepts Llc
Sources (1)
- FDA UDI c1c3c27b-a5d2-4e8e-a38e-061ae7ea819b 33 fields · synced May 30, 2026