FDA.reportPublic FDA data

XLR8 Canister

Primary DI
00849405000426
Brand
XLR8 Canister
Company
GENADYNE BIOTECHNOLOGIES INC.
Model
A4-S00D11
Device description
All canisters are made out of ABS material. It is used as a disposable item to collect patient’s exudates.
Published
2024-08-05
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
OMPNegative Pressure Wound Therapy Powered Suction Pump

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143726000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143726000XLR8 PLUS (XLR8+)Genadyne Biotechnologies, Inc.2015-06-19OMP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00849405000426PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00849405000426008494050004268494050004260849405000426

GMDN Terms#

Term, Definition table
TermDefinition
Negative-pressure wound therapy system canisterA receptacle for the collection of excess interstitial fluid, exudate, and infectious materials from a dedicated dressing that has been applied for a vacuum-assisted wound closure procedure; commonly known as negative pressure wound therapy (NPWT). It is typically made of transparent disposable plastic materials and is connected to or placed into the NPWT system's vacuum pump. This receptacle is a single-use device that should be discarded, including its contaminated waste content, according to the environmental legislation by which the user is bound (e.g., incineration, recycling, landfill).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
006616130
Device count
1
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
00849405002796Hybrid Dressing - Revo UnsterileHFD-D1040-UNS2026-03-16
00849405002802Hybrid Dressing - Revo UnsterileHFD-D1050-UNS2026-03-16
00849405002819Hybrid Dressing - Revo UnsterileHFD-D1030-UNS2026-03-16
00849405002826Hybrid Dressing - Revo UnsterileHFD-D1530-UNS2026-03-16
00849405002833Hybrid Dressing - Revo UnsterileHFD-D1520-UNS2026-03-16
00849405002840Hybrid Dressing - Revo UnsterileHFD-D1020-UNS2026-03-16
10849405002793Hybrid Dressing - Revo UnsterileHFD-D1040-UNS2026-03-16
10849405002809Hybrid Dressing - Revo UnsterileHFD-D1050-UNS2026-03-16
10849405002816Hybrid Dressing - Revo UnsterileHFD-D1030-UNS2026-03-16
10849405002823Hybrid Dressing - Revo UnsterileHFD-D1530-UNS2026-03-16
10849405002830Hybrid Dressing - Revo UnsterileHFD-D1520-UNS2026-03-16
10849405002847Hybrid Dressing - Revo UnsterileHFD-D1020-UNS2026-03-16
00849405002581Genadyne DUO NPWTA7-S00012026-03-09
00849405024101XLR8 Abdominal Wound Dressing Kit A4-ABDO1-K2026-03-09
00849405002659XLR8/XLR8+ Port - UnsterileXP-1013-UNSXP-1013-UNS2025-12-03
00849405002666XLR8 Transparent Film DressingA4-S00F5-UNSA4-S00F5-UNS2025-12-03
00849405002673Hybrid Dressing - RevoHFD-D1020HFD-D10202026-01-12
00849405002680Hybrid Dressing - RevoHFD-D1520HFD-D15202026-01-12
00849405002697Hybrid Dressing - RevoHFD-D1030HFD-D10302026-01-12
00849405002703Hybrid Dressing - RevoHFD-D1530HFD-D15302026-01-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00197998382895Solventum™ Veraflo™ Cleanse Choice™Solventum US LLCOMP2026-05-28
00849405002796Hybrid Dressing - Revo UnsterileGENADYNE BIOTECHNOLOGIES INC.OMP2026-03-16
00849405002802Hybrid Dressing - Revo UnsterileGENADYNE BIOTECHNOLOGIES INC.OMP2026-03-16
00849405002819Hybrid Dressing - Revo UnsterileGENADYNE BIOTECHNOLOGIES INC.OMP2026-03-16
00849405002826Hybrid Dressing - Revo UnsterileGENADYNE BIOTECHNOLOGIES INC.OMP2026-03-16
00849405002833Hybrid Dressing - Revo UnsterileGENADYNE BIOTECHNOLOGIES INC.OMP2026-03-16
00849405002840Hybrid Dressing - Revo UnsterileGENADYNE BIOTECHNOLOGIES INC.OMP2026-03-16
00749756392495DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-01-22
00849405002673Hybrid Dressing - RevoGENADYNE BIOTECHNOLOGIES INC.OMP2026-01-12
00849405002680Hybrid Dressing - RevoGENADYNE BIOTECHNOLOGIES INC.OMP2026-01-12
00849405002697Hybrid Dressing - RevoGENADYNE BIOTECHNOLOGIES INC.OMP2026-01-12
00849405002703Hybrid Dressing - RevoGENADYNE BIOTECHNOLOGIES INC.OMP2026-01-12
00849405002710Hybrid Dressing - RevoGENADYNE BIOTECHNOLOGIES INC.OMP2026-01-12
00849405002727Hybrid Dressing - RevoGENADYNE BIOTECHNOLOGIES INC.OMP2026-01-12
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10851978007662WoundPro+ Collection CanisterPensar Medical, LLCOMP2025-03-18
10851978007679WoundPro+ 300cc Advanced Canister w/8' TubingPensar Medical, LLCOMP2025-03-18
10851978007631WoundPro+ 300cc Advanced Canister w/5' TubingPensar Medical, LLCOMP2025-01-14
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