FDA.report

Medline

Primary DI
10080196848591
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
DYND40701
Catalog number
DYND40701
Device description
DBD-CATHETER,SUCTION,12FR,WHISTLE,W/SLV,
Published
2021-09-14
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

Contact Domains

Product Codes

CodeName
OFRTracheobronchial suction catheter kit

Product Code Classifications

CodeDeviceSpecialtyClass
OFRTracheobronchial Suction Catheter KitAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
40080196848592PrimaryGS10
10080196848591Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
4008019684859240080196848592
1008019684859110080196848591

GMDN Terms

TermDefinition
Secretion suction kitA collection of items intended for suctioning secretions from a patient; typically included are sterile gloves, a suction catheter, and a container for collecting the secretions. 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
false
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

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20080196286789MEDLINEMDT2168282MDT21682822016-10-14
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20884389108229MEDLINENONLV200XXLNONLV200XXL2025-05-27
20884389155360MEDLINENONLV240NONLV2402025-05-27
20884389155377MEDLINENONLV240XLNONLV240XL2025-05-27
20888277336893MEDLINENON50240NON502402025-05-27

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
40198459453688MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFR2025-08-11
40884389627953MEDLINEMEDLINE INDUSTRIES, INC.OFR2025-05-30
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40198459322236Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFR2025-04-18
40198459314415Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFR2025-04-07
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40198459019235Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFR2024-07-29
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40080196033318Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFR2024-06-23
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