FDA.reportPublic FDA data

SKY

Primary DI
90363739152109
Brand
SKY
Company
McKesson Corporation
Model
2395945
Device description
SKY Safety Pen Needle 30g, 5/16" (8mm)
Published
2022-07-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00363739152106PrimaryGS10
90363739152109Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00363739152106003637391521063637391521060363739152106
9036373915210990363739152109

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
140529962
Device count
100
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00010939960139Foster & ThriveBP3NP1-3EMFT(2878056)2024-09-23
00010939960153Foster & ThriveBP3NU1-3EMFT(2878072)2024-09-23
00010939960177Foster & ThriveBP3MV1-3BMFT(2878098)2024-09-23
10010939960136Foster & ThriveBP3NP1-3EMFT(2878056)2024-09-23
10010939960150Foster & ThriveBP3NU1-3EMFT(2878072)2024-09-23
10010939960174Foster & ThriveBP3MV1-3BMFT(2878098)2024-09-23
00010939960191Foster & ThriveKD-1541.F&T2024-07-23
00010939960207Foster & ThriveK-955.F&T2024-07-23
00010939960214Foster & ThriveKD-2280.F&T2024-07-23
00010939960221Foster & ThriveKD-1540.F&T2024-07-23
00010939960238Foster & ThriveKD-1780-1.F&T2024-07-23
20010939960195Foster & ThriveKD-1541.F&T2024-07-23
20010939960201Foster & ThriveK-955.F&T2024-07-23
20010939960218Foster & ThriveKD-2280.F&T2024-07-23
20010939960225Foster & ThriveKD-1540.F&T2024-07-23
20010939960232Foster & ThriveKD-1780-1.F&T2024-07-23
00010939960160Foster & ThriveBP3NM1-3WMFT(2878080)2024-06-21
10010939960167Foster & ThriveBP3NM1-3WMFT(2878080)2024-06-21
00010939960146Foster & ThriveBP3NG1-1AMFT(2878064)2024-06-19
00010939960184Foster & ThriveBPAG1-20MFT(2878106)2024-06-18

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