FDA.reportPublic FDA data

SAM Medical

Primary DI
00850068519002
Brand
SAM Medical
Company
ZIEN MEDICAL TECHNOLOGIES, INC.
Model
IO740
Device description
SAM IO Stabilizer
Published
2025-06-03
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
KMKDevice, Intravascular Catheter Securement

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMKDevice, Intravascular Catheter SecurementGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850068519019PackageGS15In Commercial Distribution
00850068519026PackageGS11In Commercial Distribution
10850068519016PackageGS16In Commercial Distribution
10850068519023PackageGS130In Commercial Distribution
00850068519002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850068519019008500685190198500685190190850068519019
00850068519026008500685190268500685190260850068519026
1085006851901610850068519016
1085006851902310850068519023
00850068519002008500685190028500685190020850068519002

GMDN Terms#

Term, Definition table
TermDefinition
Catheter/tubing connection protectorA device intended to be fitted over/around the connection juncture between a catheter and a tube, or between tubing (i.e., where there is a connector, stopcock, or valve/manifold), to create a physical barrier for protection against accidental handling and contamination. It may be in the form of a box, clip, pouch, or adhesive film and may include a foam containing a disinfectant or intended to be soaked in disinfectant prior to use. It is not intended to be adhered to the patient, nor is it designed to protect a percutaneous access site. This is a single-use device.

Regulatory Flags#

DUNS number
017535668
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850068519279SAM MedicalIO805IO8052026-05-07
00850068519309SAM MedicalIO806IO8062026-05-07
00850068519330SAM MedicalIO807IO8072026-05-07
B090MT630MorTan MT632026-02-17
B090MT2020MorTanMT202 2026-02-10
B090MT2021MorTanMT202 2026-02-10
B090XC2201450XO ConstrainXC2.20-1452026-02-03
B090XC2201451XO ConstrainXC2.20-1452026-02-03
00850068519231SAM Medical IO8422025-12-09
00850068519248SAM Medical IO847W-1P2025-12-09
00850068519255SAM Medical IO846W-1P2025-12-09
00850068519262SAM Medical IO845W-1P2025-12-09
10850068519238SAM Medical IO8422025-12-09
10850068519245SAM Medical IO847W-1P2025-12-09
10850068519252SAM Medical IO846W-1P2025-12-09
10850068519269SAM Medical IO845W-1P2025-12-09
B090P110900VentiV ScientificP11-090P11-0902025-11-24
B090P11090F0VentiV ScientificP11-090-FP11-090-F2025-11-24
B090P110901VentiV ScientificP11-090P11-0902025-11-24
B090P11090F1VentiV ScientificP11-090-FP11-090-F2025-11-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850088144284CARBOUNingbo kehu Medical Technology Co.,Ltd.KMK2026-07-08
00850088144291CARBOUNingbo kehu Medical Technology Co.,Ltd.KMK2026-07-08
00850088144307CARBOUNingbo kehu Medical Technology Co.,Ltd.KMK2026-07-08
15711055005125Drain-LokMermaid Medical A/SKMK2026-07-08
15711055012185Drain-LokMermaid Medical A/SKMK2026-07-08
10618125192592Grip-LokTIDI PRODUCTS, LLCKMK2026-06-09
00850087488303CeeportCEEPORT INC.KMK2026-05-29
00850087488310CeeportCEEPORT INC.KMK2026-05-29
00850087488327CeeportCEEPORT INC.KMK2026-05-29
00850087488334CeeportCEEPORT INC.KMK2026-05-29
00850087488341CeeportCEEPORT INC.KMK2026-05-29
00850087488358CeeportCEEPORT INC.KMK2026-05-29
10618125192585Grip-LokTIDI PRODUCTS, LLCKMK2026-04-15
10816000014070ARROWTELEFLEX INCORPORATEDKMK2025-09-16
10801741082983StatLockBard Access Systems, Inc.KMK2025-05-02
10801741087582StatLockBard Access Systems, Inc.KMK2025-05-02
10816000013868ARROWTELEFLEX INCORPORATEDKMK2025-04-04
10618125192141Grip-LokTIDI PRODUCTS, LLCKMK2024-12-02
10885632416309HalyardOWENS & MINOR DISTRIBUTION, INC.KMK2024-07-30
10885632416279HalyardOWENS & MINOR DISTRIBUTION, INC.KMK2024-07-22
10885632416286HalyardOWENS & MINOR DISTRIBUTION, INC.KMK2024-07-22
10885632416293HalyardOWENS & MINOR DISTRIBUTION, INC.KMK2024-07-22
10618125135148Grip-LokTIDI PRODUCTS, LLCKMK2024-04-22
20653160370694CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKMK2024-03-08
20653160370700CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKMK2024-03-08
20653160370717CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKMK2024-03-08
20653160370724CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKMK2024-03-08
20653160370731CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKMK2024-03-08
20653160369322MEDLINEMEDLINE INDUSTRIES, INC.KMK2023-12-01
10686004000023UltraDressingI.V. House, Inc.KMK2023-07-21