FDA.report

INJECTION TUBE

Primary DI
04048223016022
Brand
INJECTION TUBE
Company
Pajunk GmbH Medizintechnologie
Model
001151-37W
Catalog number
001151-37W
Device description
001151-37W
Published
2021-04-02
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

Related Records

Contact Domains

Product Codes

CodeName
BSOCATHETER, CONDUCTION, ANESTHETIC

Product Code Classifications

CodeDeviceSpecialtyClass
BSOCatheter, Conduction, AnestheticAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
14048223016029PreviousGS10
04048223048900PrimaryGS10
04048223016022Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
1404822301602914048223016029
04048223048900040482230489004048223048900
04048223016022040482230160224048223016022

GMDN Terms

TermDefinition
Catheter injection portA device intended to be placed on the Luer end of a catheter or intravenous (IV) tubing as a site of injection of substances into the in situ catheter/tubing. It is also intended to be used as a heparin lock by keeping the heparin flush solution in the catheter. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity65 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Contacts

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

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04048223129999Standard Sprotte Needle321151-29A321151-29A2025-09-16
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04048223131428SPROTTE®131151-30C131151-30C2025-09-16
04048223131442SPROTTE®131151-30A131151-30A2025-09-16
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04048223132050SonoPlex® II Facet S001287-72001287-722025-09-16
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04048223132395SonoPlex® II Facet001285-76001285-762025-09-16
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