FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50195594838117
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
24A6608A
Catalog number
24A6608A
Device description
MPT DART DISPOSABLE TRACH KIT
Published
2023-07-07
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
LRQTracheostomy and nasal suctioning kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRQTracheostomy And Nasal Suctioning KitUnknown1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50195594838117PackageGS13In Commercial Distribution
10195594838119PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559483811750195594838117
1019559483811910195594838119

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
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

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00850063139434Neil Medical Group Neil Medical GroupLRQ2025-12-08
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10653160387398MEDLINEMEDLINE INDUSTRIES, INC.LRQ2025-04-12
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00653160387384MEDLINEMEDLINE INDUSTRIES, INC.LRQ2025-04-12
00653160387391MEDLINEMEDLINE INDUSTRIES, INC.LRQ2025-04-12
10840330705421ProCureTwin Med, LLCLRQ2025-01-20
30840330705425ProCureTwin Med, LLCLRQ2025-01-20
10840330704240ProCureTwin Med, LLCLRQ2024-03-25
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30840330704244ProCureTwin Med, LLCLRQ2024-03-25
30840330704251ProCureTwin Med, LLCLRQ2024-03-25
10195594838119CARDINAL HEALTHCardinal Health 200, LLCLRQ2023-07-07
10653160355540MEDLINEMEDLINE INDUSTRIES, INC.LRQ2022-10-03
00840117309661Resp-O2 Tracheostomy Care Kit, One-Compartment Tray With Vinyl GlovesDynarex CorporationLRQ2022-10-03
00840117309685Resp-O2 Tracheostomy Care Kit, Three-Compartment Tray With Vinyl GlovesDynarex CorporationLRQ2022-10-03
00840117309708Resp-O2 Tracheostomy Care KitDynarex CorporationLRQ2022-10-03
00840117321359Resp-O2 Tracheostomy Care Kit, Two-Compartment Tray with Removable Plastic BasinDynarex CorporationLRQ2022-10-03
00840117321366Resp-O2 Tracheostomy Care KitDynarex CorporationLRQ2022-10-03
00840117321373Resp-O2 Tracheostomy Care KitDynarex CorporationLRQ2022-10-03
00840117321380Resp-O2 Tracheostomy Care KitDynarex CorporationLRQ2022-10-03
00840117321403Resp-O2 Tracheostomy Care Kit One-Compartment Tray Without GlovesDynarex CorporationLRQ2022-10-03
00840117321410Resp-O2 Tracheostomy Care Kit, One-Compartment Mini-Tray, Sterile Dynarex CorporationLRQ2022-10-03
00653160355543MEDLINEMEDLINE INDUSTRIES, INC.LRQ2022-10-03
10653160246466CenturionCENTURION MEDICAL PRODUCTS CORPORATIONLRQ2022-01-02
10653160251064CenturionCENTURION MEDICAL PRODUCTS CORPORATIONLRQ2022-01-02
10653160256908CenturionCENTURION MEDICAL PRODUCTS CORPORATIONLRQ2022-01-02