FDA.reportPublic FDA data

GCB Medical Supply

Primary DI
00850061859662
Brand
GCB Medical Supply
Company
GCB MEDICAL LLC
Model
GCBIVT005
Catalog number
GCBIVT005
Device description
GCB MEDICAL WIDE NECK TRANSFER HOLDER FEMALE
Published
2025-02-27
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
00850061859662PackageGS160In Commercial Distribution
00850061859761PackageGS14In Commercial Distribution
00850061859648PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850061859662008500618596628500618596620850061859662
00850061859761008500618597618500618597610850061859761
00850061859648008500618596488500618596480850061859648

GMDN Terms#

Term, Definition table
TermDefinition
Blood collection set, invasiveA collection of devices intended to be used by a healthcare professional, in combination with evacuated blood collection tubes, for the routine collection of multiple blood specimens from a patient, via one venipuncture, for clinical analyses. It consists of a blood collection needle or venous butterfly/scalp vein needle and additional devices that may include tubing, male/female Luer-lock connectors, clamps, and a blood collection tube holder. Blood access is directly through the vein with the needle. 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
false
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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Primary DI, Brand, Company table
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08586015044847CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044854CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044861CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
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10850074089091SurgycoSurgyco LLCJKA2025-12-23
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10612479275840McKessonMCKESSON MEDICAL-SURGICAL INC.JKA2025-08-14
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