FDA.reportPublic FDA data

AVANOS*

Primary DI
00193493000357
Brand
AVANOS*
Company
Avanos Medical, Inc.
Model
CRA-QPU-1-L
Catalog number
CRA-QPU-1-L
Device description
CRA-QPU-1-L AVNS,LOANER PUMP UNT,PUMP,1
Published
2021-03-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXDGenerator, lesion, radiofrequency

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXDGenerator, Lesion, RadiofrequencyNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192491000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192491000Coolief Radiofrequency Generator (CRG) SystemAvanos Medical, Inc.2020-02-21GXD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00193493000357PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00193493000357001934930003571934930003570193493000357

GMDN Terms#

Term, Definition table
TermDefinition
Cooling utility supply systemAn assembly of devices designed to provide utilities/amenities (e.g., water, compressed air) to cool other medical devices, data equipment, or laboratory devices/equipment to facilitate their operation.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(844)428-2667PIQ@AVANOS.COM

Regulatory Flags#

DUNS number
079375431
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00350770008998100mL ENFit GPro Syringe Purple Sterile120008323PNM-S100NCV2026-10-19
00350770997742MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, OTW1200011280630-142026-10-14
00350770997759MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, OTW1200011290630-202026-10-14
00350770997766MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, OTW1200014300630-242026-10-14
00350770997773MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, OTW1095814020630-142026-10-14
00350770997803MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, PULL1200014310640-142026-10-14
00350770997810MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, PULL1200014320640-202026-10-14
00350770997827MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, PULL1200014330640-242026-10-14
00350770997865MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, PULL1200014340644-142026-10-14
00350770997872MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, PULL1200014350644-202026-10-14
00350770997889MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, PULL1200014360644-242026-10-14
00350770997926MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, PULL1200014370645-142026-10-14
00350770997933MIC* Percutaneous Endoscopic Gastrostomy (PEG) Kit, 20 Fr, PULL1200014380645-202026-10-14
00350770997940MIC* Percutaneous Endoscopic Gastrostomy (PEG) Kit, 24 Fr, PULL1200014390645-242026-10-14
00350770997957MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, PULL1095831020645-142026-10-14
00193493000753GenVisc 850 Sodium Hyaluronate50653-0006-0150653-0006-012024-03-06
00193493000760TriVisc Sodium Hyaluronate50653-0006-0450653-0006-042024-03-06
00850653006016GenVisc® 850 sodium hyaluronate50653-0006-012016-10-31
00850653006047TriVisc™ sodium hyaluronate50653-0006-042018-12-20
10680651467185Halyard46718N589132017-12-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00191506048464GX1™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONGXD2025-09-29
00191506048518GX1™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONGXD2025-09-29
00191506048563GX1™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONGXD2025-09-29
00191506059309GX1™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONGXD2025-09-29
00191506059330GX1™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONGXD2025-09-29
00191506059347GX1™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONGXD2025-09-29
00191506059354GX1™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONGXD2025-09-29
05415067049650NAST. JUDE MEDICAL, INC.GXD2024-03-26
00856895008498OneRF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGXD2024-03-15
00856895008504OneRF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGXD2024-03-15
00856895008511OneRF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGXD2024-03-15
00856895008528OneRF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGXD2024-03-15
00856895008535OneRF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGXD2024-03-15
00856895008559OneRF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGXD2024-03-15
00856895008566OneRF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGXD2024-03-15
10195327563424Medline Industries, Inc.MEDLINE INDUSTRIES, INC.GXD2024-03-03
40195327563425Medline Industries, Inc.MEDLINE INDUSTRIES, INC.GXD2024-03-03
05415067034519N/AST. JUDE MEDICAL, INC.GXD2023-10-25
15415067034516N/AST. JUDE MEDICAL, INC.GXD2023-10-25
00825114000032OWLDiros Technology IncGXD2023-06-19
00852454006288RelievantRelievant Medsystems, Inc.GXD2022-12-09
00193493000692COOLIEF* Quad Pump Connector CableAvanos Medical, Inc.GXD2022-10-17
00193493000340AVANOS*Avanos Medical, Inc.GXD2021-03-03
00193493000401AVANOS*Avanos Medical, Inc.GXD2021-01-27
00193493000418AVANOS*Avanos Medical, Inc.GXD2021-01-27
00193493473021COOLIEF* Basic-R GeneratorAvanos Medical, Inc.GXD2021-01-27
00193493473038COOLIEF* Cooled RF Advanced-R GeneratorAvanos Medical, Inc.GXD2021-01-27
05415067029317IonicRF™ST. JUDE MEDICAL, INC.GXD2020-12-14
05415067033833IonicRF™ST. JUDE MEDICAL, INC.GXD2020-12-11
00193493473014COOLIEF* Cooled RF Advanced GeneratorAvanos Medical, Inc.GXD2020-10-16