FDA.report

Equashield

Primary DI
27290013484110
Brand
Equashield
Company
EQUASHIELD MEDICAL LTD
Model
Equashield Vial Adaptor Unit
Published
2016-05-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
ONBClosed Antineoplastic And Hazardous Drug Reconstitution And Transfer System

Product Code Classifications

CodeDeviceSpecialtyClass
ONBClosed Antineoplastic And Hazardous Drug Reconstitution And Transfer SystemGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
27290013484110PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2729001348411027290013484110

GMDN Terms

TermDefinition
Medication transfer setA collection of sterile devices and supplies designed to transfer parenteral medications, and sometimes intravenous (IV) fluids, between a first container(s) [e.g., a vial(s)] and a second container [e.g., an intravenous (IV) bag]; it may also be used to reconstitute medication for its preparation and administration. It is available in a variety of configurations and typically includes tubes, connectors, spike(s), syringes, and caps. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
533172743
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

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