FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106661765
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SBA11NIMMK
Catalog number
SBA11NIMMK
Device description
NICU PROCEDURE PACK
Published
2024-09-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OHGCircumcision tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHGCircumcision TrayObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106661763PackageGS15In Commercial Distribution
10197106661765PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710666176350197106661763
1019710666176510197106661765

GMDN Terms#

Term, Definition table
TermDefinition
Obstetrical/gynaecological surgical procedure kit, medicatedA collection of various sterile surgical instruments, dressings, pharmaceuticals, and materials intended to be used during obstetrical/gynaecological surgery; it is a general-purpose obstetrical/gynaecological surgical kit, and as such is not dedicated to a specific procedure. This is a single-use device.

Storage And Handling#

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

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
50192253021668Devon31160545311605452021-03-08
10192253070804Monoject118810077711881007772026-09-21
10197106862636CARDINAL HEALTHSOP54EXUCDSOP54EXUCD2026-09-21
10198956133648CARDINAL HEALTHSAN13APTMCSAN13APTMC2026-09-21
10198956219564CARDINAL HEALTHSBA19ABAEJSBA19ABAEJ2026-09-21
10198956351967CARDINAL HEALTH32A8365C32A8365C2026-09-21
10198956359147CARDINAL HEALTHSOP54FPEVCSOP54FPEVC2026-09-21
10198956373198CARDINAL HEALTHSEY73CATSESEY73CATSE2026-09-21
10198956378247CARDINAL HEALTHSOTW1CYMPDSOTW1CYMPD2026-09-21
10198956391819CARDINAL HEALTHSOPOCAPCCCSOPOCAPCCC2026-09-21
10198956395428CARDINAL HEALTHSANDHAPMPDSANDHAPMPD2026-09-21
10198956437104CARDINAL HEALTHPO11KTSSEPO11KTSSE2026-09-21
10198956439610CARDINAL HEALTHSMA23DCARNSMA23DCARN2026-09-21
10198956445857CARDINAL HEALTHPVV2MDNHFPVV2MDNHF2026-09-21
10198956450417CARDINAL HEALTHSMAMICSHHBSMAMICSHHB2026-09-21
10198956462779CARDINAL HEALTHSOP54KAATDSOP54KAATD2026-09-21
10198956468535CARDINAL HEALTHSOTOCURSTDSOTOCURSTD2026-09-21
10198956481961CARDINAL HEALTHSEY48LPNMESEY48LPNME2026-09-21
10198956487277CARDINAL HEALTHSCV3IAAUTBSCV3IAAUTB2026-09-21
10198956491786CARDINAL HEALTHSCV45MVIMBSCV45MVIMB2026-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956532977CARDINAL HEALTHCardinal Health 200, LLCOHG2026-09-04
10198956561700CARDINAL HEALTHCardinal Health 200, LLCOHG2026-09-04
10198956549548CARDINAL HEALTHCardinal Health 200, LLCOHG2026-08-26
10198956550216CARDINAL HEALTHCardinal Health 200, LLCOHG2026-08-26
10198956530485CARDINAL HEALTHCardinal Health 200, LLCOHG2026-07-27
10198956258808CARDINAL HEALTHCardinal Health 200, LLCOHG2026-07-20
10198956509405CARDINAL HEALTHCardinal Health 200, LLCOHG2026-07-16
10198956487383CARDINAL HEALTHCardinal Health 200, LLCOHG2026-06-08
10198956460119CARDINAL HEALTHCardinal Health 200, LLCOHG2026-06-03
10198956460867CARDINAL HEALTHCardinal Health 200, LLCOHG2026-06-03
10198956463882CARDINAL HEALTHCardinal Health 200, LLCOHG2026-06-01
10197106867617CARDINAL HEALTHCardinal Health 200, LLCOHG2025-07-28
10197106839775CARDINAL HEALTHCardinal Health 200, LLCOHG2025-05-27
10197106556177CARDINAL HEALTHCardinal Health 200, LLCOHG2025-02-18
10197106881255CARDINAL HEALTHCardinal Health 200, LLCOHG2025-02-13
10197106824412CARDINAL HEALTHCardinal Health 200, LLCOHG2025-01-15
10197106846117CARDINAL HEALTHCardinal Health 200, LLCOHG2025-01-14
10197106864937CARDINAL HEALTHCardinal Health 200, LLCOHG2024-12-11
10197106765364CARDINAL HEALTHCardinal Health 200, LLCOHG2024-12-04
10197106829028CARDINAL HEALTHCardinal Health 200, LLCOHG2024-11-26
10197106807903CARDINAL HEALTHCardinal Health 200, LLCOHG2024-11-25
10197106803172CARDINAL HEALTHCardinal Health 200, LLCOHG2024-11-13
10197106819746CARDINAL HEALTHCardinal Health 200, LLCOHG2024-11-13
10197106780510CARDINAL HEALTHCardinal Health 200, LLCOHG2024-11-08
10197106791189CARDINAL HEALTHCardinal Health 200, LLCOHG2024-10-31
10197106795729CARDINAL HEALTHCardinal Health 200, LLCOHG2024-10-11
10197106739754CARDINAL HEALTHCardinal Health 200, LLCOHG2024-10-01
10197106755952CARDINAL HEALTHCardinal Health 200, LLCOHG2024-09-09
10197106732694CARDINAL HEALTHCardinal Health 200, LLCOHG2024-09-06
10197106745489CARDINAL HEALTHCardinal Health 200, LLCOHG2024-08-19