FDA.reportPublic FDA data

Needle, hypodermic, single lumen

Primary DI
00858641006031
Brand
Needle, hypodermic, single lumen
Company
LIFE SCIENCE OUTSOURCING, INC.
Model
19B
Published
2016-05-03
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FMINeedle, Hypodermic, Single Lumen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K972538000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K972538000FLOW-EZE BLUNT CANNULA (1999BC)Acacia, Inc.1998-07-15FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858641006031PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858641006031008586410060318586410060310858641006031

GMDN Terms#

Term, Definition table
TermDefinition
Hypodermic needle, single-useA non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
017149456
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858641006000Set, IV, Fluid Transfer1 Pharm-62016-04-26
00858641006017Set, IV, Fluid Transfer1 Pharm-6FG2016-04-26
00858641006055Set, i.V. Fluid Transfer19MMTP2016-05-03
00858641006086Set, I.V. Fluid Transfer19TPV2016-05-03
00858641006024Syringe, Piston18B2016-04-26
00858641006048Ser, administration, intravascular19CHTP2016-05-03
00858641006079Set, Administration, Intravascular19TP2016-05-03
00858641006093Set, Administration, IntravascularDC-006-012016-05-03
00858641006109Set, Administration, IntravascularDC-012-012016-05-03
00858641006116Set, Administration, IntravascularDD-001-142016-05-03
00858641006130Set, Administration, IntravascularEB-060-022016-05-03
00858641006147Set, Administration, IntravascularEI-060-202016-05-03
00858641006154Set, Administration, IntravascularFL1000-FM2016-05-03
00858641006161Set, Administration, IntravascularFL1002-FM2016-05-03
00858641006178Set, Administration, IntravascularFS-175B2016-05-03
00858641006185Set, Administration, IntravascularSM-0132016-05-03
00858641006192Set, Administration, IntravascularSM-0162016-05-03
00858641006062Set, Administration, Intravascular19MPT2016-05-05
00858641006208Set, Administration, IntravascularEB-060-262017-03-29
00085641006123Syringe, PistonDD-001-252016-05-03

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