FDA.reportPublic FDA data

Medex

Primary DI
50351688504232
Brand
Medex
Company
SMITHS MEDICAL ASD, INC.
Model
MX920NF
Published
2020-01-13
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

Product Codes#

Code, Name table
CodeName
CBTArterial blood sampling kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBTArterial Blood Sampling KitAnesthesiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070340000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070340000SECURE ARTERIAL BLOOD SAMPLING SYSTEMSmiths Medical Asd, Inc.2007-03-15CBT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50351688504232PackageGS1100In Commercial Distribution
10351688504234PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5035168850423250351688504232
1035168850423410351688504234

GMDN Terms#

Term, Definition table
TermDefinition
Luer-ended blood collection tube spikeA device intended to be used during patient blood collection to facilitate transfer of a clinical blood specimen from blood collection tubing or a needle to a blood specimen receptacle (e.g., evacuated blood collection tube, adapted syringe). It is designed to be fitted to a blood collection tube holder, where it connects to the tubing or needle via a Luer connection at one end, and penetrates an evacuated blood collection tube at the other end for blood collection. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
828611934
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
50351688508896MedexMX207752016-10-11
50351688508933MedexMX207552016-10-11
50610674800094PortexH4003PS2015-09-01
30610674802094PortexH4021PS2015-09-01
30610674802780PortexH4022PS2015-09-01
50351688500302MedexTF562016-10-13
50351688500319MedexTF552016-12-29
50351688500487MedexSM7223SC2016-10-13
50351688500555MedexSM50142017-01-03
50351688500647MedexSM50042017-01-03
50351688500654MedexSM50032017-01-03
50351688504638MedexMX8702016-10-13
50351688505031MedexMX8012016-10-13
50351688505406MedexMX7452017-02-27
50351688505413MedexMX7432016-10-13
50351688506878MedexMX4982016-10-12
50351688506922MedexMX4922016-10-12
50351688507097MedexMX457L2016-10-12
50351688507103MedexMX4572016-10-12
50351688507189MedexMX453L2016-10-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10653160386674MEDLINEMEDLINE INDUSTRIES, INC.CBT2025-03-10
10653160384540MEDLINEMEDLINE INDUSTRIES, INC.CBT2025-01-16
10889483613092A-LineSUNMED, LLCCBT2024-05-17
10889483613108A-LineSUNMED, LLCCBT2024-05-17
10889483613115A-LineSUNMED, LLCCBT2024-05-17
10889483613122PulsetSUNMED, LLCCBT2024-05-17
10889483479407Atellica® VTR SyringesSUNMED, LLCCBT2023-06-30
10889483479414Atellica® VTR SyringesSUNMED, LLCCBT2023-06-30
10889483479469Atellica® VTR SyringesSUNMED, LLCCBT2023-06-30
10889483479476Atellica® VTR SyringesSUNMED, LLCCBT2023-06-30
10889483479483Atellica® VTR SyringesSUNMED, LLCCBT2023-06-30
10889483479490Atellica® VTR SyringesSUNMED, LLCCBT2023-06-30
10889483479506Atellica® VTR SyringesSUNMED, LLCCBT2023-06-30
10889483558249Pulset SUNMED, LLCCBT2023-06-30
10889483558256PulsetSUNMED, LLCCBT2023-06-30
10889483558263PulsetSUNMED, LLCCBT2023-06-30
10889483558270PulsetSUNMED, LLCCBT2023-06-30
10889483558287PulsetSUNMED, LLCCBT2023-06-30
10889483558294PulsetSUNMED, LLCCBT2023-06-30
10889483558300PulsetSUNMED, LLCCBT2023-06-30
10889483558317PulsetSUNMED, LLCCBT2023-06-30
10889483558331PulsetSUNMED, LLCCBT2023-06-30
10653160358329MEDLINEMEDLINE INDUSTRIES, INC.CBT2023-01-30
10653160357629MEDLINEMEDLINE INDUSTRIES, INC.CBT2022-12-20
10653160356677MEDLINEMEDLINE INDUSTRIES, INC.CBT2022-11-08
10653160355762MEDLINEMEDLINE INDUSTRIES, INC.CBT2022-10-17
10653160355472MEDLINEMEDLINE INDUSTRIES, INC.CBT2022-09-27
10653160355144CenturionCENTURION MEDICAL PRODUCTS CORPORATIONCBT2022-09-03
10653160355199MEDLINEMEDLINE INDUSTRIES, INC.CBT2022-09-03
10653160354338MEDLINEMEDLINE INDUSTRIES, INC.CBT2022-07-22