FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
40195327560516
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYKE1718C
Catalog number
DYKE1718C
Device description
BRONCHOSCOPY KIT
Published
2023-12-11
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
OFRTracheobronchial suction catheter kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFRTracheobronchial Suction Catheter KitAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40195327560516PackageGS16In Commercial Distribution
10195327560515PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019532756051640195327560516
1019532756051510195327560515

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10080196415397MEDLINEMSC97412MSC974122026-05-27
10653160393634MEDLINEDYNDV2733ADYNDV2733A2026-05-27
10653160393665MEDLINEDYNDV2772DYNDV27722026-05-27
10653160393689MEDLINEDYNDV2787DYNDV27872026-05-27
10653160393702MEDLINEDYNDV2783DYNDV27832026-05-27
10653160393719MEDLINEDYNDV2797DYNDV27972026-05-27
10653160393726MEDLINEDYNDC2483ADYNDC2483A2026-05-27
10653160393733MEDLINEDT22665ADT22665A2026-05-27
10888277415386MEDLINEMSC97410MSC974102026-05-27
10888277415393MEDLINEMSC9748MSC97482026-05-27
10888277677289MEDLINEMSC97414MSC974142026-05-27
10888277677296MEDLINEMSC9746MSC97462026-05-27
10888277177680MEDLINEMDSMR117MDSMR1172021-05-14
10884389120620MEDLINEMDSMR112MDSMR1122021-04-23
10884389120675MEDLINEMDSMPHS2MDSMPHS22021-04-23
10884389128756MEDLINEMDSMR113MDSMR1132021-04-23
10884389177679MEDLINEMDSMPHS1MDSMPHS12021-04-23
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198459453687MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFR2025-08-11
40198459453688MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFR2025-08-11
10080196033331MEDLINEMEDLINE INDUSTRIES, INC.OFR2025-06-12
10080196033348MEDLINEMEDLINE INDUSTRIES, INC.OFR2025-06-12
10080196033362MEDLINEMEDLINE INDUSTRIES, INC.OFR2025-06-12
10884389627952MEDLINEMEDLINE INDUSTRIES, INC.OFR2025-05-30
40884389627953MEDLINEMEDLINE INDUSTRIES, INC.OFR2025-05-30
10080196033355MEDLINEMEDLINE INDUSTRIES, INC.OFR2025-05-29
40080196033356MEDLINEMEDLINE INDUSTRIES, INC.OFR2025-05-29
10198459322235Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFR2025-04-18
40198459322236Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFR2025-04-18
10198459314414Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFR2025-04-07
10653160998990Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.OFR2025-04-07
40198459314415Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFR2025-04-07
40653160998991Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.OFR2025-04-07
10198459245800Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFR2025-01-26
40198459245801Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFR2025-01-26
10653160998419Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.OFR2024-12-01
40653160998410Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.OFR2024-12-01
10198459019234Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFR2024-07-29
10198459022388Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFR2024-07-29
40198459019235Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFR2024-07-29
40198459022389Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFR2024-07-29
10080196033317Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFR2024-06-23
10198459035739Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFR2024-06-23
40080196033318Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFR2024-06-23
40198459035730Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFR2024-06-23
10195327503932Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFR2023-12-21
40195327503933Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFR2023-12-21
10195327565763Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFR2023-12-17