FDA.reportPublic FDA data

MEDLINE

Primary DI
20193489190509
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
ART995
Catalog number
ART995
Device description
ARTERIAL BUNDLE NO CATHETER
Published
2020-05-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CBTArterial blood sampling kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBTArterial Blood Sampling KitAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20193489190509PackageGS120In Commercial Distribution
10193489190502PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019348919050920193489190509
1019348919050210193489190502

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA general-purpose collection of various sterile surgical instruments, dressings, and materials, including a pharmaceutical component, intended to be used to assist a range of surgical procedures across multiple clinical specialities. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463CUSTOMERSERVICE@MEDLINE.COM

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
true
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
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29
10080196137695MEDLINEDYND30351DYND303512021-11-02
10080196158522MEDLINEMDS138000MDS1380002021-05-14
10080196258598MEDLINEMDT013020457MDT0130204572016-10-14
10080196260126MEDLINEMDT013628MDT0136282016-10-14
10080196363773MEDLINEMDT013667MDT0136672016-10-14
10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
10197344039838MEDLINEHNY19100HNY191002024-10-11
10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00653160386677MEDLINEMEDLINE INDUSTRIES, INC.CBT2025-03-10
10889483581995AirLife™Sunmed Group Holdings, LLCCBT2024-12-12
30889483613096A-LineSUNMED, LLCCBT2024-05-17
30889483613102A-LineSUNMED, LLCCBT2024-05-17
30889483613119A-LineSUNMED, LLCCBT2024-05-17
30889483613126PulsetSUNMED, LLCCBT2024-05-17
30889483479401Atellica® VTR SyringesSUNMED, LLCCBT2023-06-30
30889483479418Atellica® VTR SyringesSUNMED, LLCCBT2023-06-30
30889483479463Atellica® VTR SyringesSUNMED, LLCCBT2023-06-30
30889483479470Atellica® VTR SyringesSUNMED, LLCCBT2023-06-30
30889483479487Atellica® VTR SyringesSUNMED, LLCCBT2023-06-30
30889483479494Atellica® VTR SyringesSUNMED, LLCCBT2023-06-30
30889483479500Atellica® VTR SyringesSUNMED, LLCCBT2023-06-30
30889483558243Pulset SUNMED, LLCCBT2023-06-30
30889483558250PulsetSUNMED, LLCCBT2023-06-30
30889483558267PulsetSUNMED, LLCCBT2023-06-30
30889483558274PulsetSUNMED, LLCCBT2023-06-30
30889483558281PulsetSUNMED, LLCCBT2023-06-30
30889483558298PulsetSUNMED, LLCCBT2023-06-30
30889483558304PulsetSUNMED, LLCCBT2023-06-30
30889483558311PulsetSUNMED, LLCCBT2023-06-30
10889483558324PulsetSUNMED, LLCCBT2023-06-30
30889483558335PulsetSUNMED, LLCCBT2023-06-30
04015630036684Roche MICROSAMPLER PROTECTRoche Diagnostics GmbHCBT2023-04-24
06976025820012HupaiJiangsu Chongheng Medical Technology Co., Ltd.CBT2023-03-08
00653160356670MEDLINEMEDLINE INDUSTRIES, INC.CBT2022-11-08
00653160355765MEDLINEMEDLINE INDUSTRIES, INC.CBT2022-10-17
00653160355475MEDLINEMEDLINE INDUSTRIES, INC.CBT2022-09-27
00653160355147CenturionCENTURION MEDICAL PRODUCTS CORPORATIONCBT2022-09-03
00653160355192MEDLINEMEDLINE INDUSTRIES, INC.CBT2022-09-03