FDA.reportPublic FDA data

Grip-Lok

Primary DI
00618125134533
Brand
Grip-Lok
Company
TIDI PRODUCTS, LLC
Model
3360MWA
Catalog number
3360MWA
Device description
Grip-Lok WA Medium,Universal Catheter Securement Device with Aplicare P-1010 Skin Prep Pad
Published
2022-10-19
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KMKDevice, Intravascular Catheter Securement

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMKDevice, Intravascular Catheter SecurementGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10618125134530PackageGS150Not in Commercial Distribution
00618125134533PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1061812513453010618125134530
00618125134533006181251345336181251345330618125134533

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.

Regulatory Flags#

DUNS number
063519193
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00618125135110Grip-Lok3300MWA-NSB3300MWA-NSB2022-10-18
00618125135455Grip-Lok3300MW-TA-33300MW-TA-32022-10-21
00618125134724Grip-Lok3300M-NSB3300M-NSB2022-10-18
10618125134707Grip-Lok3200S-10PK3200S-10PK2022-10-12
10618125134714Grip-Lok3300M-10PK3300M-10PK2022-10-12
10618125134769Grip-Lok3400L-10PK3400L-10PK2022-10-12
10618125134783Grip-Lok3400LFC-10PK3400LFC-10PK2022-10-13
10618125135148Grip-Lok3309MCS-TA-NSB3309MCS-TA-NSB2024-04-22
10618125192141Grip-Lok3300MWA-10PK3300MWA-10PK2024-12-02
10618125192172Grip-Lok3400LFC-10PK3400LFC-10PK2024-12-02
10618125192585Grip-LokMCGLPICC-NSBMCGLPICC-NSB2026-04-15
28481750004016Mermaid MedicalA20100090A201000902022-10-12
00618125134526Grip-Lok3460L3460L2022-10-19
00618125134687Grip-Lok3300MEPI3300MEPI2022-10-12
00618125134717Grip-Lok3300M-10PK3300M-10PK2023-06-29
00618125134748Grip-Lok3300MWA3300MWA2022-10-12
00618125134779Grip-Lok3400LFC3400LFC2022-10-13
00618125134809Grip-Lok2200NUZA2200NUZA2022-10-12
00618125134816Grip-Lok3300MIV3300MIV2022-10-12
00618125134823Grip-Lok3301MCS-BD3301MCS-BD2022-10-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850087488303CeeportCEEPORT INC.KMK2026-05-29
00850087488310CeeportCEEPORT INC.KMK2026-05-29
00850087488327CeeportCEEPORT INC.KMK2026-05-29
00850087488334CeeportCEEPORT INC.KMK2026-05-29
00850087488341CeeportCEEPORT INC.KMK2026-05-29
00850087488358CeeportCEEPORT INC.KMK2026-05-29
10618125192585Grip-LokTIDI PRODUCTS, LLCKMK2026-04-15
10816000014070ARROWTELEFLEX INCORPORATEDKMK2025-09-16
10801741082983StatLockBard Access Systems, Inc.KMK2025-05-02
10801741087582StatLockBard Access Systems, Inc.KMK2025-05-02
10816000013868ARROWTELEFLEX INCORPORATEDKMK2025-04-04
10618125192141Grip-LokTIDI PRODUCTS, LLCKMK2024-12-02
10885632416309HalyardOWENS & MINOR DISTRIBUTION, INC.KMK2024-07-30
10885632416279HalyardOWENS & MINOR DISTRIBUTION, INC.KMK2024-07-22
10885632416286HalyardOWENS & MINOR DISTRIBUTION, INC.KMK2024-07-22
10885632416293HalyardOWENS & MINOR DISTRIBUTION, INC.KMK2024-07-22
10618125135148Grip-LokTIDI PRODUCTS, LLCKMK2024-04-22
20653160370694CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKMK2024-03-08
20653160370700CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKMK2024-03-08
20653160370717CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKMK2024-03-08
20653160370724CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKMK2024-03-08
20653160370731CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKMK2024-03-08
20653160370748CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKMK2024-03-08
20653160370755CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKMK2024-03-08
20653160371073CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKMK2024-02-02
20653160369322MEDLINEMEDLINE INDUSTRIES, INC.KMK2023-12-01
10686004000023UltraDressingI.V. House, Inc.KMK2023-07-21
10686004000030UtraDressingI.V. House, Inc.KMK2023-07-21
10686004000054UltraDressingI.V. House, Inc.KMK2023-07-21
10686004000320UltraDomeI.V. House, Inc.KMK2023-07-21