FDA.report

ARROW

Primary DI
20801902114253
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN045653
Catalog number
ASK-05001-AMC1
Device description
FlexTip Plus(R) Epidural Catheterization Kit
Published
2016-09-16
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
20801902114253PackageGS15In Commercial Distribution
10801902114256PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2080190211425320801902114253
1080190211425610801902114256

GMDN Terms

TermDefinition
Epidural anaesthesia set, medicatedA collection of devices intended for the administration of an analgesic or anaesthetic agent to the epidural space for the management of pain. It includes the pharmaceutical anaesthetic agent and a needle, with additional devices utilized for the procedure (e.g., syringe, dressings), and may include a catheter (i.e., may be intended for single- or continuous-administration). It is not intended for intrathetcal anaesthesia. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store between 20 - 25°C (68 - 77°F).
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
true
Combination product
true
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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