FDA.report

Resp-O2 Single Suction Catheter, 6 FR

Primary DI
00840117310285
Brand
Resp-O2 Single Suction Catheter, 6 FR
Company
DYNAREX CORPORATION
Model
32000
Device description
Resp-O2 Single Suction Catheter, 6 FR, Sterile, Pediatric Graduated Catheter, Control Valve, Coiled Packed
Published
2022-05-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
BSYCatheters, Suction, Tracheobronchial

Product Code Classifications

CodeDeviceSpecialtyClass
BSYCatheters, Suction, TracheobronchialAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840117310292PackageGS150In Commercial Distribution
00840117310285PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117310292008401173102928401173102920840117310292
00840117310285008401173102858401173102850840117310285

GMDN Terms

TermDefinition
Airway suction catheterA 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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
008124539
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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