FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956048850
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
PVMHIVM13
Catalog number
PVMHIVM13
Device description
KIT, USGPIV
Published
2025-04-17
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
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
50198956048858PackageGS140In Commercial Distribution
10198956048850PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895604885850198956048858
1019895604885010198956048850

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.

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
10192253015553T.E.D.399539952026-06-19
20192253016748Kendall22853228532021-05-19
20192253016755Kendall2285522855-2021-02-23
20192253017455Kendall31469219314692192021-05-05
20192253017547Medi-Trace Cadence22550A22550A-2021-07-28
20192253017554Medi-Trace Cadence22550P22550P-2021-08-19
20192253017578Medi-Trace Cadence22550PC22550PC2021-07-29
20192253017585Medi-Trace Cadence22550R22550R-2021-07-29
20192253017608Medi-Trace Cadence22660R22660R-2024-02-28
20192253017622Medi-Trace Cadence22770P22770P2021-08-19
20192253017639Medi-Trace Cadence22770PC22770PC2021-07-29
20192253017721Kendall31319281313192812021-05-05
20192253018889Medi-Trace Cadence22770R22770R-2021-07-29
20192253020240Kerlix332433242020-09-22
50192253020197Kerlix189218922020-08-12
50192253020357Kerlix673567352020-08-12
50192253020364Kerlix788278822020-08-12
50192253050422Devon31142931311429312023-07-10
20192253017592Medi-Trace Cadence22660PC22660PC2021-07-29
10198956037908CARDINAL HEALTH08-3641G08-3641G2026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956446625CARDINAL HEALTHCardinal Health 200, LLCOWL2026-05-08
10198956393493CARDINAL HEALTHCardinal Health 200, LLCOWL2026-03-31
10198956291669CARDINAL HEALTHCardinal Health 200, LLCOWL2026-01-16
10198956188129CARDINAL HEALTHCardinal Health 200, LLCOWL2026-01-13
10198956266667CARDINAL HEALTHCardinal Health 200, LLCOWL2025-11-25
10198956263550CARDINAL HEALTHCardinal Health 200, LLCOWL2025-11-17
10198956257115CARDINAL HEALTHCardinal Health 200, LLCOWL2025-11-13
10198956255449CARDINAL HEALTHCardinal Health 200, LLCOWL2025-11-03
10198956229334CARDINAL HEALTHCardinal Health 200, LLCOWL2025-10-15
10198956184459CARDINAL HEALTHCardinal Health 200, LLCOWL2025-09-05
10198956165434CARDINAL HEALTHCardinal Health 200, LLCOWL2025-08-08
10197106694800CARDINAL HEALTHCardinal Health 200, LLCOWL2025-06-16
10198956067981CARDINAL HEALTHCardinal Health 200, LLCOWL2025-05-05
10198956033917CARDINAL HEALTHCardinal Health 200, LLCOWL2025-04-09
10198956024274CARDINAL HEALTHCardinal Health 200, LLCOWL2025-03-31
10198956012912CARDINAL HEALTHCardinal Health 200, LLCOWL2025-03-25
10197106982013CARDINAL HEALTHCardinal Health 200, LLCOWL2025-03-05
10197106892749CARDINAL HEALTHCardinal Health 200, LLCOWL2025-02-21
10197106953310CARDINAL HEALTHCardinal Health 200, LLCOWL2025-02-18
10197106773017CARDINAL HEALTHCardinal Health 200, LLCOWL2024-11-13
10197106650776CARDINAL HEALTHCardinal Health 200, LLCOWL2024-06-10
10197106538784CARDINAL HEALTHCardinal Health 200, LLCOWL2024-04-16
10197106611067CARDINAL HEALTHCardinal Health 200, LLCOWL2024-04-11
10197106544327CARDINAL HEALTHCardinal Health 200, LLCOWL2024-01-22
10197106499498CARDINAL HEALTHCardinal Health 200, LLCOWL2023-12-06
10197106488959CARDINAL HEALTHCardinal Health 200, LLCOWL2023-11-28
10197106427477CARDINAL HEALTHCardinal Health 200, LLCOWL2023-11-27
10197106472781CARDINAL HEALTHCardinal Health 200, LLCOWL2023-10-31
10197106442197CARDINAL HEALTHCardinal Health 200, LLCOWL2023-09-19
10197106342015CARDINAL HEALTHCardinal Health 200, LLCOWL2023-08-31