FDA.report

ARROW

Primary DI
30801902011528
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN040168
Catalog number
LR-05501
Device description
10 mL Luer-Slip Loss of Resistance Syringe
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
FMFSyringe, piston

Product Code Classifications

CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30801902011528PackageGS125Not in Commercial Distribution
00801902011527PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
3080190201152830801902011528
00801902011527008019020115278019020115270801902011527

GMDN Terms

TermDefinition
DNA-based tissue typing IVD, controlA material which is used to verify the performance of an assay intended to be used to evaluate a clinical specimen to diagnose or predict donor and recipient tissue compatibility based on one or multiple genetic markers from the major histocompatibility complex (MHC) family of genes. Genetic markers may include HLA-A, HLA-B, HLA-C, DRB1, DRB3, DRB4, DRB5, DQB1, DPB1, MICA and/or C4.

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
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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