FDA.reportPublic FDA data

Medline

Primary DI
30193489005640
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
SYR110225A
Catalog number
SYR110225A
Device description
DBD-SYR W/NDLE,HYPODERM,LL,22GX 1, 10ML
Published
2020-12-11
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMFSyringe, piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112057000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112057000KDL SYRINGES AND NEEDLEShanghai Kindly Enterprise Dev. Group Co.,2011-12-14FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20193489005643PackageGS1100In Commercial Distribution
30193489005640PackageGS1400In Commercial Distribution
10193489005646PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019348900564320193489005643
3019348900564030193489005640
1019348900564610193489005646

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose syringe, single-useA sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a needle is not included. It is intended for various medical applications and is not dedicated to medication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment to a hypodermic needle or an administration set. It is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length1Inch
Total Volume10Milliliter
Weight22Gram

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10193489024517MEDLINEMDS601LSQHFEMDS601LSQHFE2026-07-22
10888277348141MEDLINEMDS601P2MDS601P22026-07-22
10884389145517MEDLINEMDS630BSQMDS630BSQ2016-09-27
10884389145722MEDLINEMDS630LSQMDS630LSQ2016-10-14
10884389145739MEDLINEMDS630MSQMDS630MSQ2016-10-14
10884389818794MEDLINEMDS630XSQMDS630XSQ2016-09-27
20080196162410MEDLINEMPHADJDEPTH2MPHADJDEPTH22023-01-21
10080196395811MEDLINEMPH100030MPH1000302026-07-22
10653160393979MEDLINEDYNDC3596DYNDC35962026-07-21
10653160394051MEDLINEDYNDC3606DYNDC36062026-07-21
10653160394082MEDLINEDYNDC3613DYNDC36132026-07-21
10653160394099MEDLINEIV8880AIV8880A2026-07-21
10653160394105MEDLINEECVC8651ECVC86512026-07-21
10653160394112MEDLINEDYNDC3597DYNDC35972026-07-21
10653160394129MEDLINEDYNDC3611DYNDC36112026-07-21
10653160394150MEDLINEDYNDJ1156DYNDJ11562026-07-21
10653160394167MEDLINEDYNDV2742ADYNDV2742A2026-07-21
10653160394174MEDLINEECVC8390CECVC8390C2026-07-21
10653160394181MEDLINEEBSI1477CEBSI1477C2026-07-21
10653160394211MEDLINEDYNDC3605DYNDC36052026-07-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450492888Merit Medical®Merit Medical Systems, Inc.FMF2026-07-22
10383017593015Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593213Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593411Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593510Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593718Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844612Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844711Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844919Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
18257200121076O-GENESISOrthofix US LLCFMF2026-07-17
18257200121083O-GENESISOrthofix US LLCFMF2026-07-17
05391530753944Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530753951Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754217Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754620Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754699Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754941NuGen syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754965NuGen syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530753968Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754088Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754194Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754224Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754231Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530753456Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753463Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753487Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753517Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753524Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753531Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753548Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01