FDA.reportPublic FDA data

AVANOS

Primary DI
10193493000644
Brand
AVANOS
Company
Avanos Medical, Inc.
Model
181A489
Catalog number
181A489
Device description
UNIVERSAL BLOCK TRAY
Published
2022-01-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BSPNEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
OGJNerve block tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)Anesthesiology2
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 nerve-block sharp needleA sterile, sharp bevel-edged, hollow tubular metal instrument intended to invasively access a peripheral nerve to inject an anaesthetic/analgesic agent for nerve-block/pain control (e.g., sleeve blocks, deep muscle blocks, hypogastric blocks, paravertebral blocks, joint blocks, selective nerve root, lumbar sympathetic, Coeliac plexus). It may be used to deliver anaesthetic or analgesic agents directly and/or to allow introduction of a dedicated catheter for administration. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
079375431
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
00193493001088SINGLE SHOT EPIDURAL TRAY120008532182A2732026-08-21
00350770006840CORTRAK* Enteral Access System120008508P20-09502026-08-21
00350770007922CORTRAK* Enteral Access System - Reusable Cable12000625220-09662026-08-21
00350770009094CORTRAK* Enteral Access System12000890420-09502026-08-21
00350770009117CORTRAK* Enteral Access System - Reusable Cable12000887220-09662026-08-21
00350770007557CORFLO* Safety PEG Kit12000866230-53202026-08-14
00350770008868NEOMED* Oral / Enteral Syringe with ENFit® Connector120004764BA-S05NC2026-08-15
00350770008875NEOMED* Oral / Enteral Syringe with ENFit® Connector120004831BA-S12NC2026-08-15
00350770008899NEOMED* Oral / Enteral Syringe with ENFit® Connector120004839BA-S60NC2026-08-15
00350770008912NEOMED* Oral / Enteral Syringe with ENFit® Connector120004765BP-S05NC2026-08-15
00350770008929NEOMED* Oral / Enteral Syringe with ENFit® Connector120004842BP-S12NC2026-08-15
00350770008943NEOMED* Oral / Enteral Syringe with ENFit® Connector120004847BP-S60NC2026-08-15
00350770008967NEOMED* At Home Oral / Enteral Syringe with ENFit® Connector120004849NEO122026-08-15
00350770008981NEOMED* At Home Oral / Enteral Syringe with ENFit® Connector120004852NEO602026-08-15
00350770009001NEOMED* Oral / Enteral Syringe with ENFit® Connector120004832BA-S12NC-S2026-08-15
00350770009018NEOMED* Oral / Enteral Syringe with ENFit® Connector120004869PNM-S12NC2026-08-15
00350770009032NEOMED* Oral / Enteral Syringe with ENFit® Connector120004874PNM-S35NC2026-08-15
00812120004895Game Ready* System120008544550500-042026-07-31
00812120005076Game Ready* Full Leg Boot Wrap, Medium120008563590923-042026-07-31
00812120005113Game Ready* Ankle Wrap, Large120008549590330-042026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048223134030SonoPlex® II SuperCutPajunk GmbH MedizintechnologieBSP2026-08-27
04048223134054SonoPlex® II SuperCutPajunk GmbH MedizintechnologieBSP2026-08-27
04048223134078SonoPlex® II SuperCutPajunk GmbH MedizintechnologieBSP2026-08-27
04048223134092SonoPlex® II SuperCutPajunk GmbH MedizintechnologieBSP2026-08-27
10198956509498CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-08-26
10198956561878CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-08-26
B098AMS190500Aligned Medical SolutionsAligned Medical SolutionsOGJ2026-08-21
04046955966370Design Options®B. BRAUN MEDICAL INC.OGJ2026-08-17
00849233018099Busse Hospital DisposablesROBERT BUSSE & CO., INC.OGJ2026-08-14
10198956516755CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-07-31
10198956533219CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-07-31
10198956429512CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-07-27
10198956470545CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-07-27
10198956523760CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-07-27
10198956530447CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-07-27
10198956533493CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-07-27
00628725050287Nerve Block Tray Clint PharmaceuticalsCHS USA Inc.OGJ2026-07-20
00628725050294Nerve Block Tray Clint PharmaceuticalsCHS USA Inc.OGJ2026-07-20
10198956530010CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-07-20
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
04048223139110CauDal SonoPajunk GmbH MedizintechnologieBSP2026-07-06
04046955966394Design Options®B. BRAUN MEDICAL INC.OGJ2026-06-25
00849233017948Busse Hospital DisposablesROBERT BUSSE & CO., INC.OGJ2026-06-23
04048223070499NerveGuard NRFitPajunk GmbH MedizintechnologieBSP2026-06-10
04048223076217Quincke NRFitPajunk GmbH MedizintechnologieBSP2026-06-10
04048223076248Quincke NRFitPajunk GmbH MedizintechnologieBSP2026-06-10