FDA.reportPublic FDA data

MEDLINE

Primary DI
00653160353570
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
ART1010B
Catalog number
ART1010B
Device description
ARTERIAL LINE INSERTION TRAY
Published
2022-05-31
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
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
00653160353570PackageGS110In Commercial Distribution
10653160353577PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00653160353570006531603535706531603535700653160353570
1065316035357710653160353577

GMDN Terms#

Term, Definition table
TermDefinition
Arterial blood sampling kitA collection of sterile devices intended to obtain an arterial blood specimen directly from a patient, usually for the determination of blood gas concentration. It typically includes a needle, heparinized syringe, sterile gauze/swab, bandage, rubber band, stopper, and patient identification label. 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™AIRLIFECBT2024-12-12
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