FDA.reportPublic FDA data

SAM Medical

Primary DI
00850068519057
Brand
SAM Medical
Company
ZIEN MEDICAL TECHNOLOGIES, INC.
Model
IO705W
Catalog number
IO705W
Device description
The SAM IO Intraosseous Access System provides intraosseous access in the proximal tibia, distal tibia and humeral head (proximal humerus) of adults and pediatric patients, and the distal femur in pediatric patients when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases for up to 24 hours.
Published
2024-10-31
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

Product Codes#

Code, Name table
CodeName
FMINeedle, Hypodermic, Single Lumen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240915000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240915000ZIEN IO Intraosseous Access SystemZien Medical Technologies, Inc.2024-07-02FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850068519057PackageGS11In Commercial Distribution
00850068519064PackageGS15In Commercial Distribution
10850068519054PackageGS130In Commercial Distribution
10850068519061PackageGS16In Commercial Distribution
00850068519040PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850068519057008500685190578500685190570850068519057
00850068519064008500685190648500685190640850068519064
1085006851905410850068519054
1085006851906110850068519061
00850068519040008500685190408500685190400850068519040

GMDN Terms#

Term, Definition table
TermDefinition
Intraosseous infusion kitA collection of sterile devices designed to perform an intraosseous (IO) infusion (i.e., an infusion directly into the bone's medullary cavity for the purpose of administering emergency medications and other fluids). It typically consists of a needle (possibly of a special design), an inserting handle, a scalpel, an infusion set, swabs and sutures. This device is used as an alternate to the preferred intravenous (IV) route when this cannot be established in a timely manner, typically during cardiac arrest, patients with respiratory failure or in shock, and when peripheral IV infusion is very difficult. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
017535668
Device count
1
DM exempt
false
Premarket exempt
false
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
B090C140900XO Cross 14C14-090C14-0902022-06-20
B090C14090H0XO Cross 14C14-090-HC14-090-H2022-06-21
B090C141350XO Cross 14C14-135C14-1352022-06-20
B090C14135H0XO Cross 14C14-135-HC14-135-H2022-06-20
B090C141750XO Cross 14C14-175C14-1752022-06-20
B090C14175H0XO Cross 14C14-175-HC14-175-H2022-06-21
B090C35090H0XO Cross 35C35-090-HC35-090-H2022-10-24
B090C351350XO Cross 35C35-135C35-1352022-06-20
B090C35135H0XO Cross 35C35-135-HC35-135-H2022-10-24
B090C35175H0XO Cross 35C35-175-HC35-175-H2022-10-24
00853989006002XableCathXC-014-065AXC-014-065A2018-09-24
00853989006019XableCathXC-014-090AXC-014-090A2018-09-24
00853989006026XableCathXC-014-145AXC-014-145A2018-09-24
00853989006033XableCathXC-018-065AXC-018-065A2018-09-24
00853989006040XableCathXC-018-090AXC-018-090A2018-09-24
00853989006057XableCathXC-018-145AXC-018-145A2018-09-24
00853989006064XableCathXC-035-065AXC-035-065A2018-09-24
00853989006071XableCathXC-035-090AXC-035-090A2018-09-24
00853989006088XableCathXC-035-145AXC-035-145A2018-09-24
00853989006095XableCathXC-014-065BXC-014-065B2018-09-24

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