FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
10193489448993
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
CDS840215O
Catalog number
CDS840215O
Device description
FETOSCOPY CDS-LF
Published
2023-06-08
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
FCHTRAY, BIOPSY, WITHOUT BIOPSY INSTRUMENTS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCHTray, Biopsy, Without Biopsy InstrumentsGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40193489448994PackageGS12In Commercial Distribution
10193489448993PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019348944899440193489448994
1019348944899310193489448993

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.

Contacts#

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

Regulatory Flags#

DUNS number
025460908
Device count
1
Premarket exempt
true
Kit
true
Combination product
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00197344129099CURADCURCHSIL0753CURCHSIL07532026-06-09
00197344133812MEDLINEFRES2500FRES25002026-06-09
00197344133836MEDLINEFRES2501FRES25012026-06-09
00197344133850MEDLINEFRES2502FRES25022026-06-09
00197344133874MEDLINEFRES2503FRES25032026-06-09
00197344133898MEDLINEFRES2504FRES25042026-06-09
10197344142460MEDLINERTACHACMBRTACHACMB2026-06-09
10197344142477MEDLINERTACHACMGRTACHACMG2026-06-09
10197344142484MEDLINERTACHACMNRTACHACMN2026-06-09
10197344142491MEDLINERTACHACMPRTACHACMP2026-06-09
10197344142507MEDLINERTACHACMRRTACHACMR2026-06-09
10197344142514MEDLINERTACHACMYRTACHACMY2026-06-09
10197344142521MEDLINERTACHACMZRTACHACMZ2026-06-09
10197344143306MEDLINERTACHDAABRTACHDAAB2026-06-09
10197344143313MEDLINERTACHDAAGRTACHDAAG2026-06-09
10197344143320MEDLINERTACHDAANRTACHDAAN2026-06-09
10197344143337MEDLINERTACHDAAPRTACHDAAP2026-06-09
10197344143344MEDLINERTACHDAARRTACHDAAR2026-06-09
10197344143351MEDLINERTACHDAAYRTACHDAAY2026-06-09
10197344143368MEDLINERTACHDAAZRTACHDAAZ2026-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M78312011160Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.FCH2025-11-14
M78312011161Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.FCH2025-11-14
00810185250363TherapakTherapak LLCFCH2025-08-11
00810185250387TherapakTherapak LLCFCH2025-08-11
00810185250424TherapakTherapak LLCFCH2025-08-11
00810185250448TherapakTherapak LLCFCH2025-08-11
00810185250523TherapakTherapak LLCFCH2025-08-11
00810185250370TherapakTherapak LLCFCH2025-08-11
00810185250431TherapakTherapak LLCFCH2025-08-11
00810185250455TherapakTherapak LLCFCH2025-08-11
00810185250530TherapakTherapak LLCFCH2025-08-11
00810185250400TherapakTherapak LLCFCH2025-08-04
00810185250394TherapakTherapak LLCFCH2025-08-04
10809160472033HalyardAVID MEDICAL, INC.FCH2025-07-02
20809160472030HalyardAVID MEDICAL, INC.FCH2025-07-02
M78312011150Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.FCH2025-06-30
00191072239426ACSAMERICAN CONTRACT SYSTEMS, INC.FCH2025-05-27
M78312011130Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.FCH2025-04-03
M78312011120Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.FCH2025-02-28
00191072236067ACSAMERICAN CONTRACT SYSTEMS, INC.FCH2025-01-31
00191072236098ACSAMERICAN CONTRACT SYSTEMS, INC.FCH2025-01-31
00191072233714ACSAMERICAN CONTRACT SYSTEMS, INC.FCH2024-12-19
M78312011100Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.FCH2024-10-31
M78312011101Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.FCH2024-10-31
00191072231376ACSAMERICAN CONTRACT SYSTEMS, INC.FCH2024-10-21
00191072230935ACSAMERICAN CONTRACT SYSTEMS, INC.FCH2024-10-14
M78312011080Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.FCH2024-06-07
M78312011081Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.FCH2024-06-07
00191072223982ACSAMERICAN CONTRACT SYSTEMS, INC.FCH2024-05-08
00191072223999ACSAMERICAN CONTRACT SYSTEMS, INC.FCH2024-05-08