FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50887488043201
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SCV15OPRMA
Catalog number
SCV15OPRMA
Device description
STRL PEDIATRIC OFF PUMP PACK
Published
2015-10-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OEZCardiovascular procedure kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEZCardiovascular Procedure KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50887488043201PackageGS11In Commercial Distribution
00887488043206PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5088748804320150887488043201
00887488043206008874880432068874880432060887488043206

GMDN Terms#

Term, Definition table
TermDefinition
Cardiothoracic surgical procedure kit, non-medicated, single-useA collection of various sterile cardiothoracic surgical instruments, dressings, and materials intended to be used to assist a range of cardiothoracic surgical procedures; it does not contain pharmaceuticals. The kit is intended only for use during cardiothoracic surgery but is not dedicated to a specific type of cardiothoracic surgical procedure. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

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
20885380173544Curity9022G9022G2019-11-14
20885380173568Curity9024G9024G2019-11-14
10198956038127CARDINAL HEALTHSAN22IAMRASAN22IAMRA2026-10-19
10198956180000CARDINAL HEALTHPUV2KPMHBPUV2KPMHB2026-10-19
10198956268111CARDINAL HEALTHSNECGACSGESNECGACSGE2026-10-19
10198956377967CARDINAL HEALTHSBA56MIMCFSBA56MIMCF2026-10-19
10198956384774CARDINAL HEALTHSVA42LVGLCSVA42LVGLC2026-10-19
10198956390799CARDINAL HEALTHSEYCGEPAZBSEYCGEPAZB2026-10-19
10198956400795CARDINAL HEALTHSOP3MKPCVDSOP3MKPCVD2026-10-19
10198956414815CARDINAL HEALTHSMA41PGEPBSMA41PGEPB2026-10-19
10198956441811CARDINAL HEALTHSCV29VPPCUSCV29VPPCU2026-10-19
10198956462328CARDINAL HEALTHSCV13PPBTESCV13PPBTE2026-10-19
10198956464988CARDINAL HEALTHSOP51XRKKPSOP51XRKKP2026-10-19
10198956499270CARDINAL HEALTHPG33BGMKBPG33BGMKB2026-10-19
10198956499980CARDINAL HEALTH33-2528E33-2528E2026-10-19
10198956506732CARDINAL HEALTHSOP41TPDSFSOP41TPDSF2026-10-19
10198956513587CARDINAL HEALTHSAN33CACHNSAN33CACHN2026-10-19
10198956514874CARDINAL HEALTHSOPOCTKSBBSOPOCTKSBB2026-10-19
10198956516922CARDINAL HEALTHPC23TAAMEPC23TAAME2026-10-19
10198956518964CARDINAL HEALTHSAN40CCAEGSAN40CCAEG2026-10-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450113059Merit Medical®Merit Medical Systems, Inc.OEZ2026-10-20
10809160540909HalyardAVID MEDICAL, INC.OEZ2026-10-20
10198956441811CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956462328CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956516922CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956559226CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956584266CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956589476CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956589629CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956589896CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956602151CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956602205CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956602649CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956602786CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956602854CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956603844CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956604346CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956604476CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956604926CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956606432CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956606760CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956606890CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956607057CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956607170CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956609013CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956609105CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956609129CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956610583CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956611054CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956611252CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19