FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
10888277804128
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJZ10918
Catalog number
DYNJZ10918
Device description
TBG PRESS MONITOR 24IN M/F
Published
2023-07-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXOTRANSDUCER, PRESSURE, CATHETER TIP

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXOTransducer, Pressure, Catheter TipCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K925638000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K925638000PHOENIX DISPOSABLE PRESSURE TRANSDUCER #73-600Baxter Healthcare Corp1993-10-18DXO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40888277804129PackageGS1100In Commercial Distribution
10888277804128PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4088827780412940888277804129
1088827780412810888277804128

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.

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463customerservice@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10080196320493MEDLINEMDS30201MDS302012026-09-04
10080196320516MEDLINEMDS30203MDS302032026-09-05
10197344039418HUDSON RCIHUD99001KITHUD99001KIT2026-09-04
10197344043064HUDSON RCIHUD99060KITHUD99060KIT2026-09-04
10197344043071HUDSON RCIHUD99060HUD990602026-09-04
10197344043101HUDSON RCIHUD99018KITHUD99018KIT2026-09-04
10197344043118HUDSON RCIHUD99009KITHUD99009KIT2026-09-04
10197344148332MEDLINERTDCIDDHNRTDCIDDHN2026-09-04
10197344148707MEDLINERTDCIVOMRRTDCIVOMR2026-09-04
10197344204540MEDLINEMDSDAMPLGMDSDAMPLG2026-09-04
10197344204557MEDLINEMDSDAMPMGMDSDAMPMG2026-09-04
10197344204564MEDLINEMDSDAMPXLGMDSDAMPXLG2026-09-04
10888277415010MEDLINEAEG001SAEG001S2026-09-04
10888277415027MEDLINEAEG017SAEG017S2026-09-04
10080196304752MEDLINEDYNJP2203SDYNJP2203S2016-10-14
10080196714100MEDLINEDYNJP2003DYNJP20032016-10-14
10080196894536MEDLINEDYNJP6010DYNJP60102021-01-26
10884389106280MEDLINEDYND70279DYND702792023-01-27
20888277699561MEDLINENONLV340NONLV3402020-12-04
10884389393697Medline Industries, Inc.DYNJASM1DYNJASM12019-01-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885403524038TRUWAVEBecton, Dickinson And CompanyDXO2026-09-05
00885403524502TRUWAVEBecton, Dickinson And CompanyDXO2026-09-05
00885403524649TruWaveBecton, Dickinson And CompanyDXO2026-09-05
00885403525028TRUWAVEBecton, Dickinson And CompanyDXO2026-09-05
00885403525424TRUWAVE, VAMP PLUSBecton, Dickinson And CompanyDXO2026-09-05
00885403525585TRUWAVEBecton, Dickinson And CompanyDXO2026-09-05
00885403525684TruWaveBecton, Dickinson And CompanyDXO2026-09-05
00885403525943TruWaveBecton, Dickinson And CompanyDXO2026-09-05
00885403526322TruWaveBecton, Dickinson And CompanyDXO2026-09-05
00885403526599TRUWAVEBecton, Dickinson And CompanyDXO2026-09-05
00885403529897TRUWAVE,VAMPBecton, Dickinson And CompanyDXO2026-09-05
00885403539889TruWaveBecton, Dickinson And CompanyDXO2026-09-05
00885403539919TRUWAVEBecton, Dickinson And CompanyDXO2026-09-05
00885403541837TruwaveBecton, Dickinson And CompanyDXO2026-09-05
00885403541868TRUWAVEBecton, Dickinson And CompanyDXO2026-09-05
00885403542056TRUWAVEBecton, Dickinson And CompanyDXO2026-09-05
00885403542186TruWaveBecton, Dickinson And CompanyDXO2026-09-05
00885403542193TruWaveBecton, Dickinson And CompanyDXO2026-09-05
00885403542209TruWaveBecton, Dickinson And CompanyDXO2026-09-05
00885403542223TruWaveBecton, Dickinson And CompanyDXO2026-09-05
00885403542247TruWaveBecton, Dickinson And CompanyDXO2026-09-05
00885403542483TRUWAVE,VAMP JR.Becton, Dickinson And CompanyDXO2026-09-05
00885403542520TRUWAVE,VAMP JR.Becton, Dickinson And CompanyDXO2026-09-05
00885403542643TRUWAVE, VAMPBecton, Dickinson And CompanyDXO2026-09-05
00885403542667TRUWAVEBecton, Dickinson And CompanyDXO2026-09-05
00885403542704TRUWAVE, VAMP PLUSBecton, Dickinson And CompanyDXO2026-09-05
00885403542742TRUWAVE, VAMP JRBecton, Dickinson And CompanyDXO2026-09-05
00885403542803TRUWAVEBecton, Dickinson And CompanyDXO2026-09-05
00885403542810TRUWAVE, VAMP PLUSBecton, Dickinson And CompanyDXO2026-09-05
00885403524861TRUWAVE, VAMP PLUSBecton, Dickinson And CompanyDXO2026-09-04