FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50195594679635
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN45PEAHA
Catalog number
SAN45PEAHA
Device description
PERIPHERAL PACK
Published
2022-07-01
Public version status
New
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
OWLPeripheral catheter insertion kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OWLPeripheral Catheter Insertion KitGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50195594679635PackageGS13In Commercial Distribution
10195594679637PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559467963550195594679635
1019559467963710195594679637

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.

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
10192253047967Kendall92339233-2026-05-26
20192253017615Medi-Trace Cadence22661PC22661PC2021-07-29
20192253019992Kendall33547T33547T--2026-05-26
20885380136617CARDINAL HEALTHN8830N88302019-02-07
20885380136624CARDINAL HEALTHN8831N88312019-02-07
20885380136631CARDINAL HEALTHN8832N88322019-02-07
20885380168069CARDINAL HEALTHC3660PPLC3660PPL2019-04-30
10192253045093KendallMK00175MK001752023-06-15
10192253013016Argyle888875001888887500182022-10-26
10192253013023Argyle888875051388887505132022-10-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956477940CARDINAL HEALTHCardinal Health 200, LLCOWL2026-05-25
20809160517113MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.OWL2026-03-23
30849884007474VYGONVygon CorporationOWL2026-03-06
30849884007320VYGONVygon CorporationOWL2026-02-11
50198956291667CARDINAL HEALTHCardinal Health 200, LLCOWL2026-01-16
50198956188127CARDINAL HEALTHCardinal Health 200, LLCOWL2026-01-13
50198956266665CARDINAL HEALTHCardinal Health 200, LLCOWL2025-11-25
50198956263558CARDINAL HEALTHCardinal Health 200, LLCOWL2025-11-17
50198956257113CARDINAL HEALTHCardinal Health 200, LLCOWL2025-11-13
50198956184457CARDINAL HEALTHCardinal Health 200, LLCOWL2025-09-05
50198956165432CARDINAL HEALTHCardinal Health 200, LLCOWL2025-08-08
20809160486389Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OWL2025-07-22
50197106694808CARDINAL HEALTHCardinal Health 200, LLCOWL2025-06-16
10661392007663LSL HEALTHCARELSL Industries, LLCOWL2025-05-16
10661392007830LSL HEALTHCARELSL Industries, LLCOWL2025-05-16
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10661392013480LSL HEALTHCARELSL Industries, LLCOWL2025-05-16
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10661392013596LSL HEALTHCARELSL Industries, LLCOWL2025-05-16
10661392013633LSL HEALTHCARELSL Industries, LLCOWL2025-05-16
10661392025759LSL HEALTHCARELSL Industries, LLCOWL2025-05-16
10661392025827LSL HEALTHCARELSL Industries, LLCOWL2025-05-16
10661392027548LSL HEALTHCARELSL Industries, LLCOWL2025-05-16
10661392027555LSL HEALTHCARELSL Industries, LLCOWL2025-05-16
10661392027678LSL HEALTHCARELSL Industries, LLCOWL2025-05-16
10661392028309LSL HEALTHCARELSL Industries, LLCOWL2025-05-16
10661392037899LSL HEALTHCARELSL Industries, LLCOWL2025-05-16
10661392037981LSL HEALTHCARELSL Industries, LLCOWL2025-05-16