FDA.reportPublic FDA data

QUANTUM

Primary DI
10885380120756
Brand
QUANTUM
Company
Cardinal Health 200, LLC
Model
47-1230
Catalog number
47-1230
Device description
Negative Pressure Kit PRO TO GO Kit
Published
2019-02-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OMPnegative pressure wound therapy Powered suction pump

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OMPNegative Pressure Wound Therapy Powered Suction PumpGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885380120756PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088538012075610885380120756

GMDN Terms#

Term, Definition table
TermDefinition
Negative-pressure wound therapy system dressing setA collection of devices that composes a sterile dressing pack used with the pump and collection container of a negative pressure wound therapy (NPWT) system to treat hard-to-heal open wounds (e.g., acute, traumatic, and chronic) and diabetic/pressure ulcers. It typically includes dressing (e.g., open-cell foam or medicated gauze), an airtight adhesive drape, a drain, an evacuation tube, and sterile saline. This is a single-use device.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(866)484-6798xxx@xxx.xxx

Regulatory Flags#

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
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10849405002809Hybrid Dressing - Revo UnsterileGENADYNE BIOTECHNOLOGIES INC.OMP2026-03-16
10849405002816Hybrid Dressing - Revo UnsterileGENADYNE BIOTECHNOLOGIES INC.OMP2026-03-16
10849405002823Hybrid Dressing - Revo UnsterileGENADYNE BIOTECHNOLOGIES INC.OMP2026-03-16
10849405002830Hybrid Dressing - Revo UnsterileGENADYNE BIOTECHNOLOGIES INC.OMP2026-03-16
10849405002847Hybrid Dressing - Revo UnsterileGENADYNE BIOTECHNOLOGIES INC.OMP2026-03-16
00849405002581Genadyne DUO NPWTGENADYNE BIOTECHNOLOGIES INC.OMP2026-03-09
00849405024101XLR8 Abdominal Wound Dressing Kit GENADYNE BIOTECHNOLOGIES INC.OMP2026-03-09
14897089070085ExtriCAREALLEVA MEDICAL LIMITEDOMP2026-03-05
14897089070108ExtriCAREALLEVA MEDICAL LIMITEDOMP2026-03-05
04897089070330ExtricareALLEVA MEDICAL LIMITEDOMP2026-03-02
04897089070446ExtricareALLEVA MEDICAL LIMITEDOMP2026-03-02
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50749756392490DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-01-22
00849405002598Hybrid DressingGENADYNE BIOTECHNOLOGIES INC.OMP2025-12-03
00849405002659XLR8/XLR8+ Port - UnsterileGENADYNE BIOTECHNOLOGIES INC.OMP2025-12-03
00849405002666XLR8 Transparent Film DressingGENADYNE BIOTECHNOLOGIES INC.OMP2025-12-03
14897089070160ExtriCARE ALLEVA MEDICAL LIMITEDOMP2025-12-03
14897089070207ExtricareALLEVA MEDICAL LIMITEDOMP2025-12-03
10849405002595Hybrid DressingGENADYNE BIOTECHNOLOGIES INC.OMP2025-12-03
00851978007801Ultra Seal Preferred Strips (5/pouch)Pensar Medical, LLCOMP2025-12-01
00840117345539Durma+ Y-Type Suction Drainage Tube, 10 Fr Dynarex CorporationOMP2025-11-24
00840117345553Duma+ Straight Suction Drainage Tube, 10 FrDynarex CorporationOMP2025-11-24
00850590008203PWD™ Platform Wound Dressing Negative Pressure SysteAPPLIED TISSUE TECHNOLOGIES LLCOMP2025-11-20
00850590008210PWD™ Platform Wound Dressing Negative Pressure SysteMAPPLIED TISSUE TECHNOLOGIES LLCOMP2025-11-20
00850590008234PWD™ Platform Wound Dressing Negative Pressure SystemAPPLIED TISSUE TECHNOLOGIES LLCOMP2025-11-20
00850590008258PWD™ Platform Wound Dressing Negative Pressure SystemAPPLIED TISSUE TECHNOLOGIES LLCOMP2025-11-20
05000223499389RENASYSSMITH & NEPHEW MEDICAL LIMITEDOMP2025-09-23
05000223499396RENASYSSMITH & NEPHEW MEDICAL LIMITEDOMP2025-09-23
05000223499402RENASYSSMITH & NEPHEW MEDICAL LIMITEDOMP2025-09-23