FDA.report

N/A

Primary DI
50885403043817
Brand
N/A
Company
CAREFUSION 2200, INC
Model
TIN3018
Catalog number
TIN3018
Device description
ILLINOIS (TJ) BONE MARROW ASPIRATION/INTRAOSSEOUS NEEDLE 18GA
Published
2017-09-21
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
FMINeedle, hypodermic, single lumen

Product Code Classifications

CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50885403043817PackageGS110In Commercial Distribution
10885403043819PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5088540304381750885403043817
1088540304381910885403043819

GMDN Terms

TermDefinition
Body aspiration needle, single-useA sterile, sharp bevel-edged, hollow tubular metal instrument designed to remove fluid from a body cavity or to obtain a biopsy specimen from a patient through aspiration; it is not dedicated to a particular part of the anatomy. The device is typically longer than a hypodermic needle and usually has a wider hub. It is not intended for administration of pharmaceuticals. This is a single-use device.

Device Sizes

TypeValueUnit
Length3Inch
Needle Gauge18Gauge

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)323-9088gmb-MedSpec-CustService@carefusion.com
+1(800)321-4254Customer_Support@BD.com

Regulatory Flags

DUNS number
832696038
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
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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