FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
40195327503933
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNDA3034A
Catalog number
DYNDA3034A
Device description
BAL BRONCH KIT
Published
2023-12-21
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

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
40195327503933PackageGS120In Commercial Distribution
10195327503932PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019532750393340195327503933
1019532750393210195327503932

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, 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
false
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
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 DI, Brand, Company table
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
40198459019235Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFR2024-07-29
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
40195327565764Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFR2023-12-17
40195327560516Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFR2023-12-11
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
40195327273560Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFR2023-06-13
40195327277360Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFR2023-06-13
40195327265312Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFR2023-06-08
40195327362424Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFR2023-03-19
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