FDA.report

ARROW

Primary DI
50801902032893
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN040172
Catalog number
LR-05503
Device description
5 mL Luer-Lock Loss of Resistance Syringe
Published
2016-12-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
FMFSyringe, piston

Product Code Classifications

CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10801902032895PackageGS125Not in Commercial Distribution
50801902032893PackageGS11Not in Commercial Distribution
40801902032896PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1080190203289510801902032895
5080190203289350801902032893
4080190203289640801902032896

GMDN Terms

TermDefinition
Low-resistance syringeA sterile, low-friction glass or plastic barrel (cylinder) with plunger intended to be used with a needle typically to locate the epidural space. The user advances the needle until a loss of resistance (LOR) is sensed in the plunger, indicating entry into the epidural space. The syringe may then be disconnected to allow the introduction of a catheter through the needle for diagnostic or therapeutic intervention. This is a single-use device.

Device Sizes

TypeValueUnit
Length0Centimeter

Sterilization Methods

Method

Contacts

PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags

DUNS number
002348191
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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24026704941579PILLINGP13081P130812026-03-23

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