FDA.reportPublic FDA data

Disposable Infusion Bag for Parenteral Nutrition

Primary DI
06945326839542
Brand
Disposable Infusion Bag for Parenteral Nutrition
Company
Beijing L&Z Medical Technology Development Co., Ltd
Model
BEDX
Device description
The proposed device is for use in compounding and storage of parenteral nutrition solutions prior to and during administration to a patient using an intravascular administration set. The proposed device is provided sterile and single use.
Published
2024-09-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KEPMedia, Mounting, Oil Soluble

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KEPMedia, Mounting, Oil SolublePathology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222622000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222622000Disposable Infusion Bag for Parenteral NutritionBeijing L&Z Medical Technology Development Co., Ltd.2023-02-16KPE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06945326839542PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06945326839542069453268395426945326839542

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
545213456
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06945326839559Disposable Infusion Bag for Parenteral NutritionBEAP2024-10-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00196852643219AquoralK Pharmaceuticals, LLCKEP2023-07-27
10196852643216AquoralK Pharmaceuticals, LLCKEP2023-07-27