FDA.report

ARROW

Primary DI
20801902214014
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN927462
Catalog number
EF-05510N
Device description
0.2 Micron Flat NRFit(R) Epidural Filter
Published
2023-07-22
Public version status
New
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

Premarket Submissions

SubmissionSupplement
K222341000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K222341000Arrow 0.2 Micron Flat Filter, GVSArrow International, LLC2023-02-13CAZ

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20801902214014PackageGS1100In Commercial Distribution
30801902214011PackageGS11In Commercial Distribution
10801902214017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2080190221401420801902214014
3080190221401130801902214011
1080190221401710801902214017

GMDN Terms

TermDefinition
Anaesthesia conduction filterA sterile microporous membrane used to minimize particulate (foreign material) contamination of a local anaesthetic during administration to a patient (e.g., through an anaesthesia conduction catheter). This is a single-use device.

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
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
false
Sterilization required before use
false

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30841156104058SUPERCROSS530953092026-03-23
24026704941494PILLINGP12797P127972026-03-23
24026704941500PILLINGP12805P128052026-03-23
24026704941555PILLINGP13063P130632026-03-23
24026704941562PILLINGP13065P130652026-03-23
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