FDA.report

ARROW

Primary DI
30801902013775
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN040202
Catalog number
SL-05500
Device description
Single Shot Epidural Anesthesia Kit
Published
2016-09-16
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
CAZAnesthesia conduction kit

Product Code Classifications

CodeDeviceSpecialtyClass
CAZAnesthesia Conduction KitAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30801902013775PackageGS110In Commercial Distribution
00801902013774PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
3080190201377530801902013775
00801902013774008019020137748019020137740801902013774

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
Length9.84Centimeter

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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