FDA.reportPublic FDA data

Medline

Primary DI
10080196032952
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
DYND40708
Catalog number
DYND40708
Device description
DBD-CATHETER,SUCTION,8FR,DELEE,W/SLEEVE,
Published
2021-07-13
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

Contact Domains

Product Codes

CodeName
OFRTracheobronchial suction catheter kit

Product Code Classifications

CodeDeviceSpecialtyClass
OFRTracheobronchial Suction Catheter KitAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
40080196032953PrimaryGS10
10080196032952Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
4008019603295340080196032953
1008019603295210080196032952

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.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Avoid excessive heat. Protect from freezing.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags

DUNS number
025460908
Device count
50
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
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
true
Sterilization required before use
false

Other Devices From This Company

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10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29
10080196137695MEDLINEDYND30351DYND303512021-11-02
10080196158522MEDLINEMDS138000MDS1380002021-05-14
10080196258598MEDLINEMDT013020457MDT0130204572016-10-14
10080196260126MEDLINEMDT013628MDT0136282016-10-14
10080196363773MEDLINEMDT013667MDT0136672016-10-14
10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
10197344039838MEDLINEHNY19100HNY191002024-10-11
10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
40198459453688MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFR2025-08-11
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40080196033356MEDLINEMEDLINE INDUSTRIES, INC.OFR2025-05-29
40198459322236Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFR2025-04-18
40198459314415Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFR2025-04-07
40653160998991Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.OFR2025-04-07
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40653160998410Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.OFR2024-12-01
40198459019235Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFR2024-07-29
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40195327362424Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFR2023-03-19
40195327291458Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFR2022-11-27
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