FDA.report

Resp-O2 Closed Suction Endotracheal Catheter, 8 FR (2.6 mm)

Primary DI
00840117344778
Brand
Resp-O2 Closed Suction Endotracheal Catheter, 8 FR (2.6 mm)
Company
Dynarex Corporation
Model
31062
Device description
Contents: 1 Closed Suction Catheter (Neo/Pediatric) 3: Endo Tube Adaptors (3.0, 3.5 and 4.0) 1: Color Coded Depth Band Sticker 1: Change of the Day Sticker
Published
2026-05-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
00840117344693PackageGS12In Commercial Distribution
00840117344730PackageGS110In Commercial Distribution
00840117344778PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117344693008401173446938401173446930840117344693
00840117344730008401173447308401173447300840117344730
00840117344778008401173447788401173447780840117344778

GMDN Terms

TermDefinition
Tracheobronchial suction/insufflation catheter, single-lumenA sterile flexible tube designed for periodic tracheal and pharyngeal mucus aspiration and inflation of the lungs with a flow of gas from its distal tip. It consists of a single lumen tube for alternating suction and insufflation. This is a single-use device.

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
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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