FDA.reportPublic FDA data

SAM IO Intraosseous Access System

Primary DI
30822045000309
Brand
SAM IO Intraosseous Access System
Company
SAM Medical Products
Model
IO740-5P-EN
Device description
SAM IO Stabilizer - 5 Pack
Published
2020-05-28
Public version status
Update
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
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
30822045000309PackageGS16In Commercial Distribution
10822045000305PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3082204500030930822045000309
1082204500030510822045000305

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

Contacts#

Phone, Email table
PhoneEmail
5036395474quality@sammedical.com

Regulatory Flags#

DUNS number
131084188
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
false
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
00822045000001Chito-SAM™ 100CT100-C-EN2022-09-01
00822045000025Chito-SAM™ 100CT100-A-EN2022-09-01
00822045000254SAM Bleeding Control KitKT901-V-EN2022-09-01
00822045000261SAM Bleeding Control KitKT901-NV-EN2022-09-01
00822045000339Chito-SAM™ 100CT100-B-EN2022-09-01
00822045000391SAM® Junctional TourniquetJT403-EN2020-04-01
00822045428744SAM SplintSP510-OB-EN2022-09-01
00822045000179SAM Chest SealCS201-EN2022-09-01
00822045000407SAM SplintSP527-CH-EN-7572022-09-01
00822045000414SAM SplintSP527-OB-EN-5622022-09-01
00822045000438SAM SplintSP527-CH-EN-7732022-09-01
00822045000476SAM SplintSP527-OB-EN-7482022-09-01
00822045000537SAM SplintSP527-OB-EN-8032022-09-01
00822045000544SAM SplintSP527-OB-EN-8042022-09-01
00822045000551SAM Splint XLSP528-CH-EN-7862022-09-01
00822045000575SAM Splint XLSP528-OB-EN-7492022-09-01
00822045000599SAM Splint XLSP528-OB-EN-7742022-09-01
00822045000612SAM SplintSP526-CH-EN-7452022-09-01
00822045000643SAM SplintSP526-BC-EN-7052022-09-01
00822045000667SAM SplintSP526-OB-EN-5052022-09-01

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