FDA.report

SCANLAN® Special Orders

Primary DI
00846159023930
Brand
SCANLAN® Special Orders
Company
SCANLAN INTERNATIONAL INC
Model
1001-09
Catalog number
1001-09
Device description
Heparin Flushing Needle 18G-2"TDIA
Published
2018-12-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
GDMNeedle, Aspiration And Injection, Reusable

Product Code Classifications

CodeDeviceSpecialtyClass
GDMNeedle, Aspiration And Injection, ReusableGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00846159023930PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00846159023930008461590239308461590239300846159023930

GMDN Terms

TermDefinition
Catheter flush syringe connectorA sterile tubular device intended to connect to a syringe to channel a solution (e.g., sterile water) from the syringe into the proximal end of a catheter during catheter flushing. It contains a noncoring needle designed to be inserted into the catheter lumen for injection of the flushing solution. This is a single-use device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
651-297-0997vanderpoelw@scanlangroup.com

Regulatory Flags

DUNS number
023055619
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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