FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594643812
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SBA48PCNM9
Catalog number
SBA48PCNM9
Device description
PIGTAIL CHEST TUBE PACK
Published
2022-04-25
Public version status
Update
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
PYIThoracic catheter insertion tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PYIThoracic Catheter Insertion TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50195594643810PackageGS12In Commercial Distribution
10195594643812PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559464381050195594643810
1019559464381210195594643812

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
10192253067958Dover200620062026-01-15
10192253067965Dover61536153-2026-01-15
10192253067972Dover61546154-2026-01-15
10192253067989Dover812281222026-01-15
10192253067996Dover888760078488876007842026-01-15
10192253068009Dover89498949-2026-01-15
10192253068016Dover895089502026-01-15
10192253068702Dover888760077688876007762026-01-16
10192253071405CARDINAL HEALTHALMASK5ALMASK52026-04-06
10192253071412CARDINAL HEALTHAMMASK4AMMASK42026-03-23
10192253071429CARDINAL HEALTHAXLMASK6AXLMASK62026-03-23
10192253071436CARDINAL HEALTHCHIMASK3CHIMASK32026-03-23
10192253071443CARDINAL HEALTHINFMASK1INFMASK12026-03-23
10192253071450CARDINAL HEALTHNEOMASK0NEOMASK02026-03-23
10192253071467CARDINAL HEALTHTODMASK2TODMASK22026-03-23
10192253006278Genius3030963030962024-02-28
10192253006285Genius3030973030972024-02-28
10192253047486Telfa766776672025-09-08
10197106917619CARDINAL HEALTHPC15OT92CPC15OT92C2026-07-20
10198956119505CARDINAL HEALTHSVA35VCBLCSVA35VCBLC2026-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956464995CARDINAL HEALTHCardinal Health 200, LLCPYI2026-07-20
M689HHCTUINK01050Chest Tube Insertion KitSafeguard US Operating, LLCPYI2026-05-27
M689HHCTUINK0105050Chest Tube Insertion Kit Cast of 5Safeguard US Operating, LLCPYI2026-05-27
10198956361799CARDINAL HEALTHCardinal Health 200, LLCPYI2026-05-19
10198956471160CARDINAL HEALTHCardinal Health 200, LLCPYI2026-05-08
10198956453777CARDINAL HEALTHCardinal Health 200, LLCPYI2026-05-04
10198956398733CARDINAL HEALTHCardinal Health 200, LLCPYI2026-04-21
00850056748605EMS Chest Tube Insertion Kit, 24FrINTEGRATED MEDCRAFT LLCPYI2026-04-14
10198956402805CARDINAL HEALTHCardinal Health 200, LLCPYI2026-04-07
00842209138296NARNORTH AMERICAN RESCUE, LLCPYI2026-04-07
10198956433625CARDINAL HEALTHCardinal Health 200, LLCPYI2026-03-31
10198956421158CARDINAL HEALTHCardinal Health 200, LLCPYI2026-03-24
50198956421156CARDINAL HEALTHCardinal Health 200, LLCPYI2026-03-24
10198956293809CARDINAL HEALTHCardinal Health 200, LLCPYI2026-03-23
50198956293807CARDINAL HEALTHCardinal Health 200, LLCPYI2026-03-23
10198956380899CARDINAL HEALTHCardinal Health 200, LLCPYI2026-03-09
50198956380897CARDINAL HEALTHCardinal Health 200, LLCPYI2026-03-09
00850056748551Finger Thoracostomy KitINTEGRATED MEDCRAFT LLCPYI2026-03-03
10198956392564CARDINAL HEALTHCardinal Health 200, LLCPYI2026-03-02
50198956392562CARDINAL HEALTHCardinal Health 200, LLCPYI2026-03-02
10198956290310CARDINAL HEALTHCardinal Health 200, LLCPYI2026-02-23
50198956290318CARDINAL HEALTHCardinal Health 200, LLCPYI2026-02-23
10198956350748CARDINAL HEALTHCardinal Health 200, LLCPYI2026-02-13
50198956350746CARDINAL HEALTHCardinal Health 200, LLCPYI2026-02-13
00842209137459NARNORTH AMERICAN RESCUE, LLCPYI2026-02-10
10198956353114CARDINAL HEALTHCardinal Health 200, LLCPYI2026-02-09
10198956355569CARDINAL HEALTHCardinal Health 200, LLCPYI2026-02-09
50198956353112CARDINAL HEALTHCardinal Health 200, LLCPYI2026-02-09
50198956355567CARDINAL HEALTHCardinal Health 200, LLCPYI2026-02-09
10198956328396CARDINAL HEALTHCardinal Health 200, LLCPYI2026-01-30