FDA.reportPublic FDA data

GCB Medical Supply

Primary DI
00810184642725
Brand
GCB Medical Supply
Company
GCB MEDICAL LLC
Model
GCBIVT002
Catalog number
GCBIVT002
Device description
GCB MEDICAL ACCESS HOLDER WITH LUER ADAPTER
Published
2025-07-10
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
JKATubes, Vials, Systems, Serum Separators, Blood Collection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JKATubes, Vials, Systems, Serum Separators, Blood CollectionClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810184642725PackageGS1200In Commercial Distribution
00810184642855PackageGS14In Commercial Distribution
00810184642671PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810184642725008101846427258101846427250810184642725
00810184642855008101846428558101846428550810184642855
00810184642671008101846426718101846426710810184642671

GMDN Terms#

Term, Definition table
TermDefinition
Blood collection tube holder, single-useA hand-held cylindrical device designed to be used together with an evacuated blood collection tube to draw blood samples from a patient. It is typically a hollow plastic adaptor into which the blood collection tube is inserted and to which the user attaches a hypodermic blood collection needle (not included); it may include an integrated blood collection tube spike. This device also facilitates a multiple-tube blood collection via one venipuncture. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(833) 422-6331info@gcbmedicalsupply.com

Regulatory Flags#

DUNS number
086699722
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810184642152GCB Medical SupplyGCBIVT055BGCBIVT055B2026-01-28
00810184642169GCB Medical SupplyGCBIVT056BGCBIVT056B2026-01-28
00810184642176GCB Medical SupplyGCBIVT057BGCBIVT057B2026-01-28
00810184642213GCB Medical SupplyGCBIVT055BGCBIVT055B2026-01-28
00810184642220GCB Medical SupplyGCBIVT056BGCBIVT056B2026-01-28
00810184642237GCB Medical SupplyGCBIVT057BGCBIVT057B2026-01-28
00810184641292GCB Medical SupplyGCB941GCB9412025-07-31
00810184641308GCB Medical SupplyGCB941XLGCB941XL2025-07-31
00810184641315GCB Medical SupplyGCB942GCB9422025-07-31
00810184641667GCB Medical SupplyGCB941GCB9412025-07-31
00810184641674GCB Medical SupplyGCB941XLGCB941XL2025-07-31
00810184641681GCB Medical SupplyGCB942GCB9422025-07-31
00810184641322GCB Medical SupplyGCB0287GCB02872025-07-29
00850061859006GCB Medical SupplyGCB0288GCB02882025-07-29
00850061859228GCB Medical SupplyGCBHW002GCBHW0022025-07-29
00810184641698GCB Medical SupplyGCB0287GCB02872025-07-29
00850061859105GCB Medical SupplyGCB0288GCB02882025-07-29
10850061859225GCB Medical SupplyGCBHW002GCBHW0022025-07-29
00810184640974GCB Medical SupplyGCB0210BXGCB0210BX2025-07-24
00810184640981GCB Medical SupplyGCB0212GCB02122025-07-24

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