FDA.reportPublic FDA data

SONOLONG ECHO

Primary DI
04048223114025
Brand
SONOLONG ECHO
Company
Pajunk GmbH Medizintechnologie
Model
511185-31C
Catalog number
511185-31C
Device description
511185-31C
Published
2021-07-07
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
CAZAnesthesia conduction kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAZAnesthesia Conduction KitAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048223067031PreviousGS10
04048223116838PrimaryGS10
04048223114025Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048223067031040482230670314048223067031
04048223116838040482231168384048223116838
04048223114025040482231140254048223114025

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral anaesthesia catheter set, non-medicatedA collection of devices intended for the continuous-administration of an anaesthetic agent (not included) to function as a peripheral nerve-block. It includes an anaesthesia needle and an anaesthesia catheter usually with additional devices utilized for the procedure (e.g., connectors, catheter holder). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity65 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 770-493-6832info@pajunk-usa.com

Regulatory Flags#

DUNS number
317654283
Device count
10
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
04048223084366EpiLong Soft NRFit1432167-511432167-512026-05-21
04048223122235Stim2Go9151-10-009151-10-002026-05-21
04048223126103NerveStim Pure1151-94-901151-94-902026-02-06
14048223031312NiniFilter NRFit001163-38K001163-38K2020-07-22
14048223041793Filter NRFit001163-39F001163-39F2020-07-22
04048223048917FILTER001151-37X001151-37X2021-04-02
04048223049877FILTER001163-38K001163-38K2021-04-02
04048223050064FILTER001163-39F001163-39F2021-04-02
04048223069462Flat filter 0,2µm round001151-37Q001151-37Q2025-01-30
04048223069585MiniFilter 0,2µm001151-38K001151-38K2025-01-30
04048223070598Filter cannula NRFit001163-38Y001163-38Y2025-01-30
04048223120316Filter001151-62001151-622025-04-04
14048223016593Filter 0,2µm001151-37X001151-37X2016-09-29
14048223018993Quincke1149-3E1201149-3E1202020-11-03
14048223032777Tuohy cannula1150-7G1031150-7G1032020-06-09
14048223034443Tuohy1150-4G1031150-4G1032020-11-16
14048223036720UniMSK1192-4E1201192-4E1202020-07-02
14048223036737UniMSK1192-4E1501192-4E1502020-07-02
14048223038946Tuohy1150-4E1201150-4E1202020-05-06
14048223038953Tuohy1150-4G1201150-4G1202020-07-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048223128534StimuLong Sono II NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-07-30
04048223129456EpiLong TuohyPajunk GmbH MedizintechnologieCAZ2025-07-30
04048223133385EpiSpin LockPajunk GmbH MedizintechnologieCAZ2025-07-30
04048223133392EpiSpin LockPajunk GmbH MedizintechnologieCAZ2025-07-30
04048223128190SonoLong Sono NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128206SonoLong Sono NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128244StimuLong NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128312SonoLong Sono NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128343PlexoLong NanoLine® acc. MeierPajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128398SonoLong Sono NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128404SonoLong Curl EchoPajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128435PlexoLong Sono NanoLine® acc. MeierPajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128527SonoLong Sono NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128558StimuLong Sono NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128565SonoLong Echo NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128589SonoLong Echo NanoLine® NRFitPajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128596SonoLong Echo NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128602SonoLong Sono NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128626PlexoLong Sono NanoLine® acc. MeierPajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128633StimuLong Sono NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128640SonoLong Echo NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128664SonoLong Curl EchoPajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128688SonoLong Echo NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128701SonoLong Echo NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128725StimuLong NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128749StimuLong NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128756StimuLong Sono NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128763StimuLong Sono NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128787StimuLong NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128800StimuLong Sono NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17