FDA.reportPublic FDA data

ambIT

Primary DI
00850000509047
Brand
ambIT
Company
SUMMIT MEDICAL PRODUCTS, INC.
Model
220573
Catalog number
220573
Device description
PIB/PCA v1.5 Pain Control System-Basic
Published
2020-04-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OFQAnesthesia Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFQAnesthesia KitAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20850000509041PackageGS15In Commercial Distribution
00850000509047PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2085000050904120850000509041
00850000509047008500005090478500005090470850000509047

GMDN Terms#

Term, Definition table
TermDefinition
Electric infusion pump administration set, single-useA collection of sterile devices (e.g., plastic tubing, check valve, roller clamp, Y-site connector, Luer, needle/catheter) intended to be used in combination with an electrically-powered infusion pump for the intravenous (IV), subcutaneous, intramuscular, or epidural administration of medication. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
831704841
Device count
1
Premarket exempt
true
Kit
true
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
00857595005022ambIT2204182204182016-09-09
00850000509238MediBag2205822205822021-06-10
10850000509235MediBag2205822205822021-06-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10198956569584CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-09-29
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10198956581470CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-09-25
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10198956572560CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-09-21
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10198956577091CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-09-21
10198956465510CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-09-04
10198956535558CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-09-04
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10198956538818CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-09-04
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10198956461734CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-07-27
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10198956530706CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-07-27
10198956531024CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-07-27
10198956531031CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-07-27