FDA.report

Medline Industries, Inc.

Primary DI
40198459019235
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYKE1718F
Catalog number
DYKE1718F
Device description
BRONCHOSCOPY KIT
Published
2024-07-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
40198459019235PackageGS16In Commercial Distribution
10198459019234PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
4019845901923540198459019235
1019845901923410198459019234

GMDN Terms

TermDefinition
General surgical procedure kit, medicatedA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, and that includes a pharmaceutical component, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
025460908
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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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10884389110010MEDLINECRI5000BCRI5000B2026-03-24
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30193489036224MEDLINEMDSE2RDCAMDSE2RDCA2022-12-10
30193489036248MEDLINEMDSE2RDCPMDSE2RDCP2022-12-10
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40888277170972MEDLINEFG1503FG15032026-03-20
40888277358455MEDLINEMPHPN315MPHPN3152026-03-19
40888277358462MEDLINEMPHPN318MPHPN3182026-03-19
20197344009807HUDSON RCIHUD2417HUD24172026-03-19
20080196286789MEDLINEMDT2168282MDT21682822016-10-14
20080196765574MEDLINE INDUSTRIES, INC.NONLV200NONLV2002025-05-28
10197344010264HUDSON RCIHUD1846HUD18462026-03-19
20884389108199MEDLINE INDUSTRIES, INC.NONLV200XXXLNONLV200XXXL2024-03-05
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
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
40198459245801Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFR2025-01-26
40653160998410Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.OFR2024-12-01
40198459022389Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFR2024-07-29
40080196033318Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFR2024-06-23
40198459035730Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFR2024-06-23
40195327503933Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFR2023-12-21
40195327565764Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFR2023-12-17
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40080196033370MedlineMEDLINE INDUSTRIES, INC.OFR2023-10-06
40080196033394MedlineMEDLINE INDUSTRIES, INC.OFR2023-10-06
40080196033455MedlineMEDLINE INDUSTRIES, INC.OFR2023-10-06
40080196033479MedlineMEDLINE INDUSTRIES, INC.OFR2023-10-06
40080196033523MedlineMEDLINE INDUSTRIES, INC.OFR2023-10-06
40195327509478Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFR2023-10-01
40195327476824Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFR2023-08-13
40195327471850Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFR2023-08-06
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40195327291458Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFR2022-11-27
40195327222391Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFR2022-11-24
40195327233816Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFR2022-08-28
40195327212408Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFR2022-07-31