FDA.reportPublic FDA data

StatLock

Primary DI
10801741188869
Brand
StatLock
Company
Bard Access Systems, Inc.
Model
SEC2404321
Catalog number
SEC2404321
Device description
Dressing, Securis Non-Sterile
Published
2020-04-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KGXTape and bandage, adhesive
KMKDEVICE, INTRAVASCULAR CATHETER SECUREMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGXTape And Bandage, AdhesiveGeneral Hospital1
KMKDevice, Intravascular Catheter SecurementGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20801741188866PackageGS110In Commercial Distribution
10801741188869PrimaryGS10
00801741188862Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2080174118886620801741188866
1080174118886910801741188869
00801741188862008017411888628017411888620801741188862

GMDN Terms#

Term, Definition table
TermDefinition
Wearable percutaneous catheter/tube holder, single-useA noninvasive device designed to fix a percutaneous (excluding intracranial) catheter, tube, and/or drain (e.g., IV, epidural, or drainage catheter, GI tube) to a patient's body; it may additionally be intended for holding a non-surgically-invasive tube (e.g., nasogastric tube) to the patient (universal holder). It is designed as an adhesive pad, a base plate, strip, or bandage that will attach to the patient's skin, and may include holes to allow suture fixation. The exposed side may have integrated fixation mechanism to hold the catheter/tube in place and may include a transparent film portion intended for fixation site monitoring. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)545-0890medical.services@crbard.com

Regulatory Flags#

DUNS number
044611812
Device count
500
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00801741087004Groshong771255077125502016-06-07
00801741235207PowerPICCCK001087CK0010872026-06-24
00801741235214PowerPICC ProvenaCK001088CK0010882026-06-24
00801741240102ProvenaCK001092ACK001092A2026-06-24
00801741240034PowerPICC SOLOCK001093CK0010932026-05-27
00801741240041PowerPICC Provena SOLOCK001094CK0010942026-05-27
00801741240058PowerPICC Provena SOLOCK001095CK0010952026-05-27
00801741240065PowerPICC Provena SOLO Catheter with Sherlock 3CGCK001096CK0010962026-05-27
00801741240072PowerPICC Provena SOLO Catheter with Sherlock 3CGCK001097CK0010972026-05-27
10801741082983StatLockS04020010S040200102025-05-02
10801741087582StatLockD05000002AD05000002A2025-05-02
10801741188852StatLockSEC2404320SEC24043202020-04-22
00801741075452SecurisSEC0100SEC01002019-10-17
00801741081248StatLock068400047206840004722025-05-02
00801741081255StatLock068400049306840004932025-05-02
00801741081521STATLOCKCV0223CV02232023-11-09
00801741081552STATLOCKCV0226CV02262023-11-09
00801741081576STATLOCKCV0321CV03212023-11-09
00801741081675STATLOCKIB0200IB02002023-11-09
00801741081682STATLOCKIV0220IV02202023-11-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
069740214114323H MedicalWAL-MART STORES, INC.KGX2026-07-31
069740214114943H MedicalWAL-MART STORES, INC.KGX2026-07-31
06979191882112NanacareWAL-MART STORES, INC.KGX2026-07-31
06979191882228NanacareWAL-MART STORES, INC.KGX2026-07-31
06979191882242NanacareWAL-MART STORES, INC.KGX2026-07-31
06979191882273BadBuddyWAL-MART STORES, INC.KGX2026-07-31
06979191883591OKTAPEHTT Technologies, Inc.KGX2026-07-31
06979191883607OKTAPEHTT Technologies, Inc.KGX2026-07-31
06979191883690EQUATEWAL-MART STORES, INC.KGX2026-07-31
06979191883706EQUATEWAL-MART STORES, INC.KGX2026-07-31
06979191883713EQUATEWAL-MART STORES, INC.KGX2026-07-31
06979191883720EquateWAL-MART STORES, INC.KGX2026-07-31
06980297490019HuixiangJiangsu Huixiang Intelligent Technology Co., LtdKGX2026-07-31
20618125192339AquaGuardTIDI PRODUCTS, LLCKGX2026-07-28
20618125192384AquaGuardTIDI PRODUCTS, LLCKGX2026-07-28
20618125192391AquaGuardTIDI PRODUCTS, LLCKGX2026-07-28
00850086064003BRIJ-SEALBRIJ Medical, Inc.KGX2026-07-17
B14350202030IDcheck SensorBeacon Biosignals, Inc.KGX2026-07-17
00850088144598CARBOUNingbo kehu Medical Technology Co.,Ltd.KGX2026-07-10
00850088144284CARBOUNingbo kehu Medical Technology Co.,Ltd.KMK2026-07-08
00850088144291CARBOUNingbo kehu Medical Technology Co.,Ltd.KMK2026-07-08
00850088144307CARBOUNingbo kehu Medical Technology Co.,Ltd.KMK2026-07-08
15711055005125Drain-LokMermaid Medical A/SKMK2026-07-08
15711055012185Drain-LokMermaid Medical A/SKMK2026-07-08
00850088144093CARBOUNingbo kehu Medical Technology Co.,Ltd.KGX2026-07-01
14931921902902BLUPRO Attachment TapeNIHON KOHDEN CORPORATIONKGX2026-06-23
00850087488556CeeportCEEPORT INC.KGX2026-06-12
16973405130119AODEJIANWenzhou Anqi Medical Supplies Co., LtdKGX2026-06-10
00049696189583THERA PlusFOURSTAR GROUP INC.KGX2026-06-09
00049696561228THERA PlusFOURSTAR GROUP INC.KGX2026-06-09