FDA.reportPublic FDA data

ambIT

Primary DI
00857595005022
Brand
ambIT
Company
SUMMIT MEDICAL PRODUCTS, INC.
Model
220418
Catalog number
220418
Device description
Introducer- 8 inch
Published
2016-09-09
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
BSOCatheter, Conduction, Anesthetic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSOCatheter, Conduction, AnestheticAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20857595005026PackageGS110In Commercial Distribution
00857595005022PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2085759500502620857595005026
00857595005022008575950050228575950050220857595005022

GMDN Terms#

Term, Definition table
TermDefinition
Subcutaneous tunneller, single-useA hand-held manual surgical instrument designed to create a subcutaneous tunnel (artificial passageway) between percutaneous entry and exit incisions for the subcutaneous placement of a device (e.g., catheter for medication administration, shunt). It is available in a variety of forms and may be: 1) a luminal sheath with a removable inner obturator, intended for co-axial device introduction, followed by sheath removal; or 2) a non-luminal device intended to either lead or pull the device through subcutaneous tissue. It is not intended for tunnelling through deep tissues and is not a dedicated pacing or defibrillation lead tunneller. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
(801) 352-1888service@ambitpump.com

Regulatory Flags#

DUNS number
831704841
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850000509078ambIT2205712205712020-08-17
00857595005923ambIT 2205402205402020-05-06
00850000509023ambIT2205462205462020-04-23
00850000509030ambIT2205722205722020-04-23
00857595005572ambIT2202442202442016-09-09
00857595005589ambIT2202622202622016-09-09
00857595005596ambIT2203262203262016-09-09
00857595005602ambIT2204262204262016-09-09
00857595005619ambIT2204522204522016-09-09
00857595005626ambIT2204612204612016-09-09
00857595005640ambIT2204682204682016-09-09
00857595005664ambIT2204762204762016-09-09
00857595005671ambIT2204372204372016-09-09
00857595005688ambIT2205012205012017-12-18
00857595005695ambIT220501Y220501Y2018-02-27
00857595005817ambIT2205342205342018-07-16
00857595005824ambIT 2205272205272018-06-21
00850000509238MediBag2205822205822021-06-10
10850000509235MediBag2205822205822021-06-10
00857595005442Micro iBlade220497A220497A2016-11-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10801902197570ARROWTELEFLEX INCORPORATEDBSO2022-11-09
10801902197587ARROWTELEFLEX INCORPORATEDBSO2022-11-09
10801902197631ARROWTELEFLEX INCORPORATEDBSO2022-11-09
10801902197723ARROWTELEFLEX INCORPORATEDBSO2022-11-09
10801902197730ARROWTELEFLEX INCORPORATEDBSO2022-11-09
10801902200614ARROWTELEFLEX INCORPORATEDBSO2022-11-09
10801902201444ARROWTELEFLEX INCORPORATEDBSO2022-11-09
10801902201468ARROWTELEFLEX INCORPORATEDBSO2022-11-09
10801902192636ARROWTELEFLEX INCORPORATEDBSO2022-11-08
10801902194579ARROWTELEFLEX INCORPORATEDBSO2022-11-08
10801902194586ARROWTELEFLEX INCORPORATEDBSO2022-11-08
10801902207484ARROWTELEFLEX INCORPORATEDBSO2022-09-14
10801902207521ARROWTELEFLEX INCORPORATEDBSO2022-09-14
10801902207545ARROWTELEFLEX INCORPORATEDBSO2022-09-14
10801902207699ARROWTELEFLEX INCORPORATEDBSO2022-09-14
10801902207705ARROWTELEFLEX INCORPORATEDBSO2022-09-14
10801902207712ARROWTELEFLEX INCORPORATEDBSO2022-09-14
10801902207811ARROWTELEFLEX INCORPORATEDBSO2022-09-14
10801902207620ARROWTELEFLEX INCORPORATEDBSO2022-07-07
10801902207507ARROWTELEFLEX INCORPORATEDBSO2022-05-13
10801902207835ARROWTELEFLEX INCORPORATEDBSO2022-05-11
10801902207569ARROWTELEFLEX INCORPORATEDBSO2022-04-29
10801902207682ARROWTELEFLEX INCORPORATEDBSO2022-04-29
10801902207743ARROWTELEFLEX INCORPORATEDBSO2022-04-29
10801902207842ARROWTELEFLEX INCORPORATEDBSO2022-04-29
10801902207446ARROWTELEFLEX INCORPORATEDBSO2022-04-11
10801902207668ARROWTELEFLEX INCORPORATEDBSO2022-04-11
10801902207736ARROWTELEFLEX INCORPORATEDBSO2022-04-11