FDA.reportPublic FDA data

GVS

Primary DI
20810197810177
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
OTC
false
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
119067149
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810197810460GVSLPS2KLE2026-02-19
20810197810467GVSLPS2KLE2026-02-19
10810197810170GVSSQ40s2026-01-19

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
10810197810170GVSGvs 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