FDA.reportPublic FDA data

AVANOS

Primary DI
00193493000647
Brand
AVANOS
Company
Avanos Medical, Inc.
Model
181A489
Catalog number
181A489
Device description
UNIVERSAL BLOCK TRAY
Published
2022-01-26
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
OGJNerve block tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OGJNerve Block TrayAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K000495000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K000495000BALLARD MEDICAL PRODUCTS EPIDURAL AND SPINAL NEEDLESBallard Medical Products2000-03-28BSP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10193493000644PackageGS110In Commercial Distribution
00193493000647PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1019349300064410193493000644
00193493000647001934930006471934930006470193493000647

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral anaesthesia single-administration set, medicatedA collection of devices intended for the single-administration of an anaesthetic agent to function as a peripheral nerve-block. It includes a pharmaceutical anaesthetic agent with an anaesthesia needle and a syringe often with additional devices utilized for the procedure (e.g., dressings); as a single-administration set it does not include a catheter. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
079375431
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00350770456096CLOG ZAPPER* with Applicator12000154520-00022019-06-21
10680651458350Halyard4583525-0082017-09-18
10680651458367Halyard4583625-0102017-09-18
10680651458374Halyard4583725-0122017-09-18
10680651469035Halyard4690325-0142017-09-18
10680651469042Halyard4690425-0162017-09-18
10680651469059Halyard4690525-0182017-09-18
00193494135263AVANOS*500108750010872020-09-25
10680651124767COOLIEF* Cooled Radiofrequency QUICKCLAMP* Device12476SIA-QC2016-05-17
00812120005083Game Ready* 6' Dual Connector Hose, Rental120004997570302-RN2026-04-24
00812120005090Game Ready* 6' Medical Connector Hose, Rental120004999570304-RN2026-04-24
00812120005106Game Ready* Wrap Extender Strap Kit, Rental120004998573226-RN2026-04-17
00609038351117AVANOS35111351112020-04-01
00609038351124AVANOS35112351122020-04-01
00609038351131AVANOS35113351132020-04-01
00609038351148AVANOS35114351142020-04-01
00609038351155AVANOS35115351152020-04-01
00609038351162AVANOS35116351162020-04-01
00609038351179AVANOS35117351172020-04-01
00609038351186AVANOS35118351182020-04-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00628725050188Nerve Block TrayCHS USA Inc.OGJ2026-07-17
00628725050195Nerve Block TrayCHS USA Inc.OGJ2026-07-17
00628725050201Nerve Block TrayCHS USA Inc.OGJ2026-07-17
10198956500785CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-07-09
10198956524620CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-07-09
04046955966394Design Options®B. BRAUN MEDICAL INC.OGJ2026-06-25
00849233017948Busse Hospital DisposablesROBERT BUSSE & CO., INC.OGJ2026-06-23
10198956481176CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-06-05
10198956458451CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-06-01
00849233014329Busse Hospital DisposablesROBERT BUSSE & CO., INC.OGJ2026-03-25
00628725050003Nerve Block TrayCHS USA Inc.OGJ2025-11-20
00628725050010Nerve Block TrayCHS USA Inc.OGJ2025-11-20
10195327297756Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2023-06-13
10193489212969Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2023-06-08
10193489215441Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2023-06-08
10193489215885Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2023-06-08
10193489217667Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2023-06-08
10193489415827Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2023-06-08
10193489422481Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2023-06-08
10193489426816Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2023-06-08
10193489428780Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2023-06-08
10193489432077Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2023-06-08
10193489432817Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2023-06-08
10193489445497Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2023-06-08
10193489447156Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2023-06-08
10193489454994Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2023-06-08
10193489810479Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2023-06-08
H65857032375Henry ScheinHENRY SCHEIN, INC.OGJ2022-12-13
10195327243142Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2022-11-24
H65857032195Henry ScheinHENRY SCHEIN, INC.OGJ2022-10-25