FDA.reportPublic FDA data

Rospital Productos Medicos

Primary DI
00812460027899
Brand
Rospital Productos Medicos
Company
ATLAS MEDICAL PRODUCTS LLC
Model
RBC23
Catalog number
RBC23
Device description
"NON-SAFETY (REGULAR) BLOOD COLLECTION SET 23G X 3/4"", Each"
Published
2020-09-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FMINeedle, Hypodermic, Single Lumen
JKATubes, Vials, Systems, Serum Separators, Blood Collection
KSTSystem, Blood Collection, Vacuum-Assisted, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2
JKATubes, Vials, Systems, Serum Separators, Blood CollectionClinical Chemistry2
KSTSystem, Blood Collection, Vacuum-Assisted, ManualHematology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K000369000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K000369000VACUFLOW+ BLOOD COLLECTION SET, MODEL 52221/3/5; VACUFLOW+ WITH HOLDER BLOOD COLLECTION SET, MODEL 82021/3/5 WITH HOLDERMedpro Technologies, Inc.2000-03-30FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10812460027896PackageGS1100In Commercial Distribution
20812460027893PackageGS110In Commercial Distribution
00812460027899PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081246002789610812460027896
2081246002789320812460027893
00812460027899008124600278998124600278990812460027899

GMDN Terms#

Term, Definition table
TermDefinition
Blood collection set, invasiveA collection of devices intended to be used by a healthcare professional, in combination with evacuated blood collection tubes, for the routine collection of multiple blood specimens from a patient, via one venipuncture, for clinical analyses. It consists of a blood collection needle or venous butterfly/scalp vein needle and additional devices that may include tubing, male/female Luer-lock connectors, clamps, and a blood collection tube holder. Blood access is directly through the vein with the needle. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Contacts#

Phone, Email table
PhoneEmail
7864739436levalenzuela17@gmail.com

Regulatory Flags#

DUNS number
013112308
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812460027035Rospital Productos MedicosSY10WNSY10WN2020-06-13
00812460027059Rospital Productos MedicosSY10215SY102152020-06-13
00812460020777Rospital Productos MedicosGS4021262022-10-21
00812460020821Rospital Productos MedicosCW500101CW5001012022-10-21
00812460021965Rospital Productos MedicosGS4021284021282022-10-21
00812460025086Rospital Productos MedicosGS402122GS4021222022-10-21
00812460028131Rospital Productos MedicosFM3501FM35012020-09-29
00812460020395ROSPITAL PRODUCTOS MEDICOSELSELS2024-08-23
10812460020392ROSPITAL PRODUCTOS MEDICOSELSELS2024-08-23
00812460021484ROSPITAL PRODUCTOS MEDICOSELSPELSP2024-08-23
00812460024799ROSPITAL PRODUCTOS MEDICOSESPWHESPWH2024-08-23
00812460024768Rospital Producos MedicosSY05WN31516SY05WN315162024-04-16
00812460024775Rospital Productos MedicosSY05WN32516SY05WN325162024-04-16
00812460024782Rospital Productos MedicosSY05WN3012SY05WN30122024-04-16
00812460026243Rospital Productos MedicosSY1WN32516SY1WN325162024-04-16
00812460026274Rospital Productos MedicosSY1WN3012SY1WN30122024-04-16
00812460026298Rospital Productos MedicosSY1WN31516SY1WN315162024-04-16
10812460024765Rospital Producos MedicosSY05WN31516SY05WN315162024-04-16
10812460024772Rospital Productos MedicosSY05WN32516SY05WN325162024-04-16
10812460024789Rospital Productos MedicosSY05WN3012SY05WN30122024-04-16

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