FDA.reportPublic FDA data

Walgreens

Primary DI
00311917048154
Brand
Walgreens
Company
WALGREEN CO.
Model
654882
Catalog number
928858
Device description
Walgreens THIN Insulin Syringes 0.3mL 31Gauge 5/16" (8mm) U-100 100count
Published
2016-12-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMFSyringe, piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50311917048159PackageGS15In Commercial Distribution
50382909288587PackageGS15Not in Commercial Distribution
00311917048154PrimaryGS10
80382909288588Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5031191704815950311917048159
5038290928858750382909288587
00311917048154003119170481543119170481540311917048154
8038290928858880382909288588

GMDN Terms#

Term, Definition table
TermDefinition
Insulin syringe/needle, basicA sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used to administer an injection of insulin to a patient subcutaneously; a non-retractable needle is included, either attached or detached (usually capped for user protection). The syringe is typically made of plastic and silicone materials and will have plunger anti-sticking properties allowing smooth plunger movement. It can be used by healthcare personnel or patient, and will allow for the aspiration of the pharmaceutical from its container for direct administration to the patient or via an intravenous (IV) port, heparin lock, or saline lock. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0
Needle Gauge0
Total Volume0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Room Temperature

Contacts#

Phone, Email table
PhoneEmail
888-772-3212consumerrelations.pq@walgreens.com

Regulatory Flags#

DUNS number
008965063
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
00311917014920Walgreens6772579288522016-12-20
00311917025360Walgreens6545679288572016-12-20
00311917085685Walgreens7208802026-05-08
00311917085692Walgreens7208932026-05-08
00311917085739Walgreens7208942026-05-08
00311917085753Walgreens7208922026-05-08
00311917085760Walgreens7208972026-05-08
00311917077598Walgreens7377342026-04-28
00311917151434Walgreens2205442019-11-29
00311917151472Walgreens2205502019-11-28
00311917219288Walgreens2729422020-11-26
00311917219295Walgreens2729432020-11-26
00311917064635Walgreens351587 2025-06-20
00311917006239Walgreens2964622023-01-25
00311917065724Walgreens8246332025-04-29
00311917065731Walgreens8246322025-04-29
00311917065762WALGREENS8416972025-04-29
00311917065779WALGREENS7456072025-04-29
00311917066585WALGREENS8360682025-04-29
00311917199603WALGREENS8281472022-03-25

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Primary DI, Brand, Company table
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05391530753654Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753661Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753678Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01