FDA.reportPublic FDA data

MediBag

Primary DI
10850000509235
Brand
MediBag
Company
SUMMIT MEDICAL PRODUCTS, INC.
Model
220582
Catalog number
220582
Device description
MediBag 420 ml w/ Nuraxial Connector
Published
2021-06-10
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
KPEContainer, I.V.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPEContainer, I.V.General Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K001287000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K001287000EMPTY RESERVOIR BAG, 50 ML,100 ML,250 ML,500 ML, 1000M ML, 1500 ML, 2000 ML, 3000 MLSorenson Medical, Inc.2000-06-09KPE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850000509235PackageGS130In Commercial Distribution
20850000509232PackageGS160In Commercial Distribution
00850000509238PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085000050923510850000509235
2085000050923220850000509232
00850000509238008500005092388500005092380850000509238

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous administration bag/bottleAn empty pouch or bottle made of plastic or glass intended to contain a fluid (e.g., saline, medication) for intravenous (IV) administration; some types may in addition be intended for enteral feeding applications. It may be composed of one or more chambers and might be provided with a short length of tubing; however, it does not include other associated items (e.g., clamp, spike) [i.e., not an IV administration set] and is not intended to be directly connected to the IV catheter. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume420Milliliter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8013521888service@ambitmpi.com

Regulatory Flags#

DUNS number
831704841
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
true
Sterilization required before use
false

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
00857595005442Micro iBlade220497A220497A2016-11-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
18859299123612eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2026-04-10
18859299123629eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2026-04-10
18859299123636eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2026-04-10
18859299124589eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2026-04-10
08056209145105EVA TPN BAGSVALMED SRLKPE2026-02-02
08056209145112EVA TPN BAGSVALMED SRLKPE2026-02-02
18033737862282EVA TPN BagsVALMED SRLKPE2025-12-31
10748426139726Medline-MicrotekMicrotek Medical LLCKPE2025-10-10
10748426139672Medline-MicrotekMicrotek Medical LLCKPE2025-10-08
10748426139719Medline-MicrotekMicrotek Medical LLCKPE2025-10-08
18859299136131eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-09-11
18859299136148eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-09-11
18859299136155eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-09-11
20192253056706ChemoPlusCardinal Health 200, LLCKPE2025-08-22
20192253056713ChemoPlusCardinal Health 200, LLCKPE2025-08-22
18859299136179eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-07-31
18859299136032eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-06-06
18859299136049eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-06-06
18859299136063eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-06-06
18859299136070eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-06-06
18859299136087eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-06-06
18859299136117eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-06-06
10612479272122McKessonMCKESSON MEDICAL-SURGICAL INC.KPE2024-08-21
10612479272146McKessonMCKESSON MEDICAL-SURGICAL INC.KPE2024-08-21
10612479272160McKessonMCKESSON MEDICAL-SURGICAL INC.KPE2024-08-21
10612479272184McKessonMCKESSON MEDICAL-SURGICAL INC.KPE2024-08-21
10612479272207McKessonMCKESSON MEDICAL-SURGICAL INC.KPE2024-08-21
10612479272221McKessonMCKESSON MEDICAL-SURGICAL INC.KPE2024-08-21
10612479272245McKessonMCKESSON MEDICAL-SURGICAL INC.KPE2024-08-21
10612479272269McKessonMCKESSON MEDICAL-SURGICAL INC.KPE2024-08-21