FDA.reportPublic FDA data

CellSHILED

Primary DI
07290020288059
Brand
CellSHILED
Company
EQUASHIELD MEDICAL LTD
Model
SU-35/2-CL
Device description
CellSHIELD Syringe Unit 35ml
Published
2025-07-20
Public version status
New
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
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290020288056PackageGS120In Commercial Distribution
27290020288053PackageGS180In Commercial Distribution
07290020288059PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729002028805617290020288056
2729002028805327290020288053
07290020288059072900202880597290020288059

GMDN Terms#

Term, Definition table
TermDefinition
Compounding transfer setA collection of sterile items typically used in the clinical pharmacy or a manufacturing plant to provide a sterile fluid path for the compounding (mixing) of different multi-ingredient solutions from multiple source containers into a final suitable container. It is typically available in a variety of configurations (e.g., as a 6-lead or a 9-lead set) and includes, e.g., tubes, connectors, spikes. This device may also be used for intravenous (IV) solution compounding. This is a single-use device.

Regulatory Flags#

DUNS number
533172743
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290013484871EQUASHIELD CSTDFC-1PC2026-05-26
07290020288004CellSHILEDSU-1/2-CL2025-07-20
07290020288011CellSHILEDSU-3/2-CL2025-07-20
07290020288028CellSHILEDSU-5/2-CL2025-07-20
07290020288035CellSHILEDCellSHIELD Syringe Unit 10ml2025-07-20
07290020288042CellSHILEDSU-20/2-CL2025-07-20
07290020288066CellSHILEDSU-60/2-CL2025-07-20
07290020288073CellSHILEDVA-13/2-CL2025-07-20
07290020288080CellSHILEDVA-20/2-CL2025-07-20
07290020288097CellSHILEDSK-1/2-CL2025-07-20
07290020288103CellSHILEDSK-3/2-CL2025-07-20
07290020288110CellSHILEDSK-5/2-CL2025-07-20
07290020288127CellSHILEDSK-10/2-CL2025-07-20
07290020288134CellSHILEDSK-20/2-CL2025-07-20
07290020288141CellSHILEDSK-35/2-CL2025-07-20
07290020288158CellSHILEDSK-60/2-CL2025-07-20
07290020288165CellSHILEDLL-Set-CL2025-07-20
07290020288172CellSHILEDLL-2-CL2025-07-20
07290020288189CellSHILEDLL-1-CL2025-07-20
17290020288001CellSHILEDSU-1/2-CL2025-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08435389828150SAMPLE PREPARATION KITBIOTECHNOLOGY INSTITUTE SLLXG2026-05-27
00816394021855Helmer ScientificHELMER, INC.LXG2026-05-13
00816394021930Helmer ScientificHELMER, INC.LXG2026-05-13
00816394021947Helmer ScientificHELMER, INC.LXG2026-05-13
00816394021954Helmer ScientificHELMER, INC.LXG2026-05-13
00816394021985Helmer ScientificHELMER, INC.LXG2026-05-13
00816394021992Helmer ScientificHELMER, INC.LXG2026-05-13
00816394022005Helmer ScientificHELMER, INC.LXG2026-05-13
00816394022012Helmer ScientificHELMER, INC.LXG2026-05-13
00816394022050Helmer ScientificHELMER, INC.LXG2026-05-13
00816394022067Helmer ScientificHELMER, INC.LXG2026-05-13
00816394022074Helmer ScientificHELMER, INC.LXG2026-05-13
00816394022081Helmer ScientificHELMER, INC.LXG2026-05-13
15099590695743iChemVELOCITYBECKMAN COULTER IRELAND INC.LXG2026-04-27
09120123910022Anchor Tips, 300uLSTRATEC Consumables GmbHLXG2026-01-14
26974573531033CellproSuzhou CellPro Biotechnology Co., Ltd.LXG2025-11-21
10818207025071Endocator Starter KitVista DentalLXG2025-11-07
10818207025088Endocator Swabs (20pk)Vista DentalLXG2025-11-07
00810100050269KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100050283KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100050306KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100050511KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100050528KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100050535KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100050542KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100050559KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100050603KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100050610KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100051297KBMEDKB Medical (group), Inc.LXG2025-05-22
20885380197861CARDINAL HEALTHCardinal Health 200, LLCLXG2025-04-18