FDA.report

ARROW

Primary DI
50801902005125
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN045606
Catalog number
AK-05501
Device description
Epidural Catheterization Kit with FlexTip Plus(R), Open Tip Single-Port Catheter and Needle Disposal Feature
Published
2018-10-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
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
50801902005125PackageGS110In Commercial Distribution
40801902005128PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5080190200512550801902005125
4080190200512840801902005128

GMDN Terms

TermDefinition
Anaesthesia conduction catheterA flexible tube intended to be percutaneously introduced for the repeated or continuous injection of local anaesthetics for preoperative, intraoperative, or postoperative regional anaesthesia and/or pain management; it may be placed in the epidural space, into or around surgical wound sites, and near peripheral nerves. It may include devices dedicated to catheter introduction/function (e.g., needle, sheath); it is not coated with an antimicrobial agent. This device is typically used during surgical or diagnostic procedures or for the temporary relief of chronic pain in the limbs, pelvis, abdomen, or lumbar spine. This is a single-use device intended to be used in a sterile condition.

Device Sizes

TypeValueUnit
Length90Centimeter

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

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
false
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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