FDA.reportPublic FDA data

NAMIC

Primary DI
20193489069140
Brand
NAMIC
Company
MEDLINE INDUSTRIES, INC.
Model
91301308
Catalog number
91301308
Device description
ANGIO KIT STD W/PERC. MANIFOLD PG
Published
2022-02-24
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
DRSTransducer, blood-pressure, extravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRSTransducer, Blood-Pressure, ExtravascularCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20193489069140PackageGS110In Commercial Distribution
10193489069143PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019348906914020193489069140
1019348906914310193489069143

GMDN Terms#

Term, Definition table
TermDefinition
Invasive-pressure external transducer, single-useA sterile, noninvasive, non-luminal, electronic device designed to be connected to an appropriate invasive luminal device (e.g., catheter, cannula, tube, needle), to detect pressures (e.g., blood, gastrointestinal, urinary pressures) within the lumen and transmit them as electrical signals to an appropriate monitoring device. It consists of a pressure transducer and a connection cable and may be designed to be used with a pressure transducer dome. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
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
10887709175980ICU Medical, Inc.ICU MEDICAL, INC.DRS2026-02-16
10887709175997ICU Medical, Inc.ICU MEDICAL, INC.DRS2026-02-16
10887709176000ICU Medical, Inc.ICU MEDICAL, INC.DRS2026-02-16
10887709128092ICU Medical, Inc.ICU MEDICAL, INC.DRS2025-04-08
08886483503854ACCUTRANS™ Disposable Pressure Monitoring SystemBIOPTIMAL INTERNATIONAL PTE. LTD.DRS2025-01-22
00690103201079Acumen IQEdwards Lifesciences LLCDRS2024-09-23
50690103200930Acumen IQEdwards Lifesciences LLCDRS2024-08-27
50690103200954Acumen IQEdwards Lifesciences LLCDRS2024-08-27
50690103200978ACUMEN IQ SENSOREdwards Lifesciences LLCDRS2024-08-27
00690103201093Acumen IQEdwards Lifesciences LLCDRS2024-08-27
00690103201109ACUMEN IQ SENSOREdwards Lifesciences LLCDRS2024-08-27
00840619028152Transpac™/Transtar™ICU MEDICAL, INC.DRS2024-08-20
00840619037185Transpac™/Transtar™ICU MEDICAL, INC.DRS2024-08-20
00840619045104Transpac™/Transtar™ICU MEDICAL, INC.DRS2024-08-20
00840619065102Transpac™/Transtar™ICU MEDICAL, INC.DRS2024-08-20
00840619067212Transpac™/Transtar™ICU MEDICAL, INC.DRS2024-08-20
00840619097257Transpac™/Transtar™ICU MEDICAL, INC.DRS2024-08-20
00887709044838Transpac™/Transtar™ICU MEDICAL, INC.DRS2024-08-20
00887709045255Transpac™/Transtar™ICU MEDICAL, INC.DRS2024-08-20
00887709045293Transpac™/Transtar™ICU MEDICAL, INC.DRS2024-08-20
00887709045460Transpac™/Transtar™ICU MEDICAL, INC.DRS2024-08-20
00887709070684Transpac™/Transtar™ICU MEDICAL, INC.DRS2024-08-20
00887709089280Transpac™/Transtar™ICU MEDICAL, INC.DRS2024-08-20
00887709121416Transpac™/Transtar™ICU MEDICAL, INC.DRS2024-08-20
00887709127494Transpac™/Transtar™ICU MEDICAL, INC.DRS2024-08-20
00887709127500Transpac™/Transtar™ICU MEDICAL, INC.DRS2024-08-20
00887709127517Transpac™/Transtar™ICU MEDICAL, INC.DRS2024-08-20
00887709127524Transpac™/Transtar™ICU MEDICAL, INC.DRS2024-08-20
00887709127531Transpac™/Transtar™ICU MEDICAL, INC.DRS2024-08-20
00887709127548Transpac™/Transtar™ICU MEDICAL, INC.DRS2024-08-20