FDA.reportPublic FDA data

GVS

Primary DI
10810197810170
Brand
GVS
Company
Gvs Tm, Inc.
Model
SQ40s
Device description
Blood Transfusion Filter
Published
2026-01-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
CAKMicrofilter, Blood Transfusion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAKMicrofilter, Blood TransfusionGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K960993000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K960993000PALL SQ40S BLOOD FILTER (SQ40S/SQ40ST)Pall Biomedical Products Co.1996-04-22CAK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20810197810177PackageGS140In Commercial Distribution
10810197810170PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2081019781017720810197810177
1081019781017010810197810170

GMDN Terms#

Term, Definition table
TermDefinition
Blood transfusion filterA microporous device intended to be inserted, e.g., into a blood transfusion line, to remove debris from blood being infused into a patient. When used for arterial blood the device may also be used to trap gaseous (air) bubbles. This is a single-use device.

Regulatory Flags#

DUNS number
119067149
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810197810460GVSLPS2KLE2026-02-19
20810197810467GVSLPS2KLE2026-02-19
20810197810177GVSSQ40s2026-01-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10810197810460GVSGvs Tm, Inc.CAK2026-02-19
20810197810467GVSGvs Tm, Inc.CAK2026-02-19
20810197810177GVSGvs Tm, Inc.CAK2026-01-19
04052682004308LeukoconnectFresenius Kabi AGCAK2022-06-02
14052682004305LeukoconnectFresenius Kabi AGCAK2022-06-02
10887691000178HaemoneticsHAEMONETICS CORPORATIONCAK2022-03-15
10887691000543HaemoneticsHAEMONETICS CORPORATIONCAK2022-03-15
30887691000172HaemoneticsHAEMONETICS CORPORATIONCAK2022-03-15
30887691000547HaemoneticsHAEMONETICS CORPORATIONCAK2022-03-15
10887691000666HaemoneticsHAEMONETICS CORPORATIONCAK2021-03-19
30887691000660HaemoneticsHAEMONETICS CORPORATIONCAK2021-03-19
20887691308745Leukocyte SC RCHAEMONETICS CORPORATIONCAK2017-06-16
30887691308742Leukocyte SC RCHAEMONETICS CORPORATIONCAK2017-06-16
10887691000673HaemoneticsHAEMONETICS CORPORATIONCAK2017-02-06
10887691305792HaemoneticsHAEMONETICS CORPORATIONCAK2017-02-06
30887691000677HaemoneticsHAEMONETICS CORPORATIONCAK2017-02-06
30887691305796HaemoneticsHAEMONETICS CORPORATIONCAK2017-02-06
10887691000550PXL 8HAEMONETICS CORPORATIONCAK2017-02-02
10887691000581RCXL1HAEMONETICS CORPORATIONCAK2017-02-02
10887691000680HaemoneticsHAEMONETICS CORPORATIONCAK2017-02-02
30887691000554PXL 8HAEMONETICS CORPORATIONCAK2017-02-02
30887691000585RCXL1HAEMONETICS CORPORATIONCAK2017-02-02
30887691000684HaemoneticsHAEMONETICS CORPORATIONCAK2017-02-02
10887691000758HaemoneticsHAEMONETICS CORPORATIONCAK2017-01-19
10887691001243LipiGuard SBHAEMONETICS CORPORATIONCAK2017-01-19
10887691304214Haemonetics Leukotrap SC RCHAEMONETICS CORPORATIONCAK2017-01-19
10887691305303HaemoneticsHAEMONETICS CORPORATIONCAK2017-01-19
30887691000752HaemoneticsHAEMONETICS CORPORATIONCAK2017-01-19
30887691001247LipiGuard SBHAEMONETICS CORPORATIONCAK2017-01-19
30887691304218Haemonetics Leukotrap SC RCHAEMONETICS CORPORATIONCAK2017-01-19