FDA.reportPublic FDA data

SAM Medical

Primary DI
00850068519026
Brand
SAM Medical
Company
ZIEN MEDICAL TECHNOLOGIES, INC.
Model
IO740
Device description
SAM IO Stabilizer
Published
2025-06-03
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
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 small, rigid box/clip/pouch 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 include a foam containing a disinfectant or intended to be soaked in disinfectant prior to use. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
017535668
Device count
1
DM exempt
false
Premarket exempt
true
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B090MT2021MorTanMT202 2026-02-10
B090XC2201451XO ConstrainXC2.20-1452026-02-03
10850068519238SAM Medical IO8422025-12-09
10850068519245SAM Medical IO847W-1P2025-12-09
10850068519252SAM Medical IO846W-1P2025-12-09
10850068519269SAM Medical IO845W-1P2025-12-09
B090P110901VentiV ScientificP11-090P11-0902025-11-24
B090P11090F1VentiV ScientificP11-090-FP11-090-F2025-11-24
10850049994863Syntervention 4008-2032025-09-26
10850049994870Syntervention 4008-3032025-09-26
10850049994887Syntervention 4008-4032025-09-26
10850049994894Syntervention 4008-2052025-09-26
10850049994900Syntervention 4008-3052025-09-26
10850049994917Syntervention 4008-4052025-09-26
10850049994924Syntervention 4008-2072025-09-26
10850049994931Syntervention 4008-3072025-09-26
10850049994948Syntervention 4008-4072025-09-26
10850049994955Syntervention 4008-2092025-09-26
10850049994962Syntervention 4008-3092025-09-26
10850049994979Syntervention4007-4092025-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860009369436Cathaid NextGenCathaid IncorporatedKMK2026-10-01
00860009369450Cathaid NextGenCathaid IncorporatedKMK2026-10-01
00197998343353Solventum™ Tegaderm™Solventum US LLCKMK2026-08-23
00197998343384Solventum™ Tegaderm™Solventum US LLCKMK2026-08-23
00197998343407Solventum™ Tegaderm™Solventum US LLCKMK2026-08-23
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
00850068519002SAM MedicalZien Medical Technologies, LLCKMK2025-06-03
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
10686004000023UltraDressingI.V. House, Inc.KMK2023-07-21