FDA.reportPublic FDA data

Ceros

Primary DI
10850060997775
Brand
Ceros
Company
Rhino Medical Supply Inc
Model
RM-SNO132015LS
Catalog number
RM-SNO132015LS
Device description
Ceros Safety Hypodermic Needle and Syringe Combo, 3 mL 20 G x 1 1/2" Yellow Luer Lock Tip Hub, Latex Free, DEHP Free, PVC Free
Published
2024-03-19
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
FMINeedle, Hypodermic, Single Lumen

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193526000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193526000Syringe with safety needle, Safety needleJiangsu Caina Medical Co.,Ltd2020-07-17FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850060997775PackageGS1100In Commercial Distribution
20850060997772PackageGS112In Commercial Distribution
00850060997778PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085006099777510850060997775
2085006099777220850060997772
00850060997778008500609977788500609977780850060997778

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose syringe/needleA 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 non-retractable needle is included, either attached or detached (usually capped for user protection). It is intended for various medical applications and is not dedicated to medication administration. The syringe 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
Length1.5Inch
Needle Gauge20Gauge
Total Volume3Milliliter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
833-997-4466info@rhinomedicalsupply.com

Regulatory Flags#

DUNS number
117524559
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850060997983CerosRM-SN122705RM-SN1227052026-02-23
10850060997980CerosRM-SN122705RM-SN1227052026-02-23
00850041572444CerosRM-SN121815RM-SN1218152026-01-27
00850041572536CerosRM-SN122310RM-SN1223102026-01-27
00850060997952CerosRM-SN122510RM-SN1225102026-01-27
00850060997969CerosRM-SN122515RM-SN1225152026-01-27
00850060997976CerosRM-SN122558RM-SN1225582026-01-27
10850041572441CerosRM-SN121815RM-SN1218152026-01-27
10850041572533CerosRM-SN122310RM-SN1223102026-01-27
10850060997959CerosRM-SN122510RM-SN1225102026-01-27
10850060997966CerosRM-SN122515RM-SN1225152026-01-27
10850060997973CerosRM-SN122558RM-SN1225582026-01-27
00850060997440CerosRM-SN15BRM-SN15B2024-03-18
00850060997457CerosRM-SN15DRM-SN15D2024-03-19
00850060997464CerosRM-SN15ERM-SN15E2024-03-19
00850060997433CerosRM-SN15ARM-SN15A2024-03-18
00810192690114CerosRM-PF1203RM-PF12032025-11-18
00810192690619CerosRM-PF1210SFRM-PF1210SF2025-11-18
00810192690701CerosRM-CST1410RM-CST14102025-11-18
00810192690053CerosRM-PF1210RM-PF12102025-11-18

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