FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956576575
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SPK3365513
Catalog number
SPK3365513
Device description
KIT, PUSH PULL FLUID RESUSCITA
Published
2026-09-04
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

Product Codes#

Code, Name table
CodeName
LRPTRAY, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRPTray, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956576573PackageGS145In Commercial Distribution
10198956576575PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895657657350198956576573
1019895657657510198956576575

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.

Regulatory Flags#

DUNS number
961027315
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
true
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
10198956037908CARDINAL HEALTH08-3641G08-3641G2026-09-04
10198956210240CARDINAL HEALTHAMN213116EAMN213116E2026-09-04
10198956310933CARDINAL HEALTHANE439532GANE439532G2026-09-04
10198956331891CARDINAL HEALTHSAN13ARBIFSAN13ARBIF2026-09-04
10198956333420CARDINAL HEALTHSANX4IPSSCSANX4IPSSC2026-09-04
10198956359291CARDINAL HEALTHSMA54BGEVCSMA54BGEVC2026-09-04
10198956379084CARDINAL HEALTHSOP33EXMSGSOP33EXMSG2026-09-04
10198956395947CARDINAL HEALTHSOPMIMPMSBSOPMIMPMSB2026-09-04
10198956398467CARDINAL HEALTHSBA44LPCEASBA44LPCEA2026-09-04
10198956415195CARDINAL HEALTHSCVCGOHILHSCVCGOHILH2026-09-04
10198956421462CARDINAL HEALTHSOPMVSAUCJSOPMVSAUCJ2026-09-04
10198956426061CARDINAL HEALTHSCVDKMVOGDSCVDKMVOGD2026-09-04
10198956428102CARDINAL HEALTHSAN13RDEMSSAN13RDEMS2026-09-04
10198956454989CARDINAL HEALTHSOP23KPNLCSOP23KPNLC2026-09-04
10198956462977CARDINAL HEALTHSBA48LCRHCSBA48LCRHC2026-09-04
10198956463394CARDINAL HEALTHSEN23TAPCLSEN23TAPCL2026-09-04
10198956464520CARDINAL HEALTHSMA23GPNVBSMA23GPNVB2026-09-04
10198956465510CARDINAL HEALTH34-3217C34-3217C2026-09-04
10198956468399CARDINAL HEALTHPO1DTHAMQPO1DTHAMQ2026-09-04
10198956468481CARDINAL HEALTHSMAOCGLSTGSMAOCGLSTG2026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956210240CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956310933CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956480322CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956538337CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956546431CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956564503CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956572713CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956573963CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956575622CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956577404CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956578166CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956578364CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956578715CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956578739CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956578876CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956580046CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956580060CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956580237CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956581258CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956581463CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956581487CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956583573CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956583641CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956583856CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956520790CARDINAL HEALTHCardinal Health 200, LLCLRP2026-08-26
10198956521001CARDINAL HEALTHCardinal Health 200, LLCLRP2026-08-26
10198956568228CARDINAL HEALTHCardinal Health 200, LLCLRP2026-08-26
10198956569348CARDINAL HEALTHCardinal Health 200, LLCLRP2026-08-26
10198956569843CARDINAL HEALTHCardinal Health 200, LLCLRP2026-08-26
10198956570009CARDINAL HEALTHCardinal Health 200, LLCLRP2026-08-26