FDA UDI
In Commercial Distribution
🇺🇸 United States
SuctionShield
DI: 00861283000305
·
Model: PSC5300
·
PATIENT SHIELD CONCEPTS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- SuctionShield
- Primary DI
- 00861283000305
- Version / Model
- PSC5300
- Company Name
- PATIENT SHIELD CONCEPTS, LLC
- Labeler DUNS
- 193277717
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-08
- Public Version
- 3
- Public Version Date
- 2020-04-20
- Public Version Status
- Update
- Public Device Record Key
- c3fd5755-6aa6-489a-aa0f-707a4c140f0a
Device 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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JOL | Catheter And Tip, Suction | General Hospital | 880.6740 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 10749 | Airway suction catheter | A flexible tube designed to be inserted through the mouth, artificial airway, tracheostomy tube, and/or nostrils, for periodic aspiration of liquids and/or semi-solids from a patient's airway (e.g., pharynx, trachea, bronchi, nasal cavity) as part of a suction system; it is not intended to inflate the lungs. It is typically made of polymer with a smooth and rounded distal-tip, often including end and side holes and a finger-controlled valve to regulate suction. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00861283000305 | GS1 |