FDA.report

Medline

Primary DI
30080196449402
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
SYR103205
Catalog number
SYR103205
Device description
SYR W/NDLE,HYPODERM,LL,20GX1", 3ML
Published
2022-02-18
Public version status
New
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
FMFSyringe, piston

Product Code Classifications

CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30080196449402PackageGS1100In Commercial Distribution
40080196449409PackageGS1800In Commercial Distribution
10080196449408PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3008019644940230080196449402
4008019644940940080196449409
1008019644940810080196449408

GMDN Terms

TermDefinition
Non-fixed blood collection needleA sharp bevel-edged, hollow tubular metal instrument intended to be used as part of a blood collection set for drawing blood from a patient; it does not include wings for fixation/placement (i.e., not a venous butterfly/scalp vein needle). It is intended to be connected to blood collection tubing and/or a blood collection Luer connector for transfer into a blood specimen receptacle. It may include a pre-attached blood collection tube spike and/or a safety cover; however, it does not include blood collection tubing or a tube holder (i.e., not a set). This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags

DUNS number
025460908
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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