FDA.reportPublic FDA data

GARYLINE

Primary DI
00661948011710
Brand
GARYLINE
Company
Garyline LLC
Model
PZ53-CK-2
Catalog number
PZ53-CK-1
Published
2024-03-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
OHOFirst Aid Kit Without Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHOFirst Aid Kit Without DrugGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00661948011710PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00661948011710006619480117106619480117100661948011710

GMDN Terms#

Term, Definition table
TermDefinition
First aid kit, non-medicated, reusableA convenient collection of equipment and materials intended to be used in an emergency for the rapid, initial treatment of an injury. This device is typically used by emergency medical services (EMS), institutions, schools, the home, motor vehicles, and other public settings. This device does not contain medicinal substances/pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
001619337
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00661948011796GARYLINEFA341-CCFA341-CC2024-06-25
00661948011765GARYLINECK-CONTENTS-12024-06-17
00661948011758GARYLINEHSK3A-ALTHSK3A-ALT2024-05-14
00661948011727GARYLINEDPCT64SNCT64SN2024-03-21
00661948004125GARYLINEWFA6WFA62024-01-12
00661948011703GARYLINEDPFA341-NOMEDDPFA341-NOMED2024-01-11
00661948102005GARYLINEFA1239-CK-GLA052FA1239-CK-GLA0522024-01-04
00661948009922GARYLINEWFA4WFA42024-01-02
00661948011901GARYLINEWFA5WFA52024-01-02
00661948011918GARYLINEFA16-PB5FA16-PB52024-01-02
00661948004392GARYLINEWFA3WFA32023-12-18
00661948011246GARYLINEPZ600-A-CKPZ600-A-CK2023-12-14
00661948004378GARYLINEFA74FA742023-12-07
00661948004040GARYLINEDPPZTKDPPZTK2023-11-27
00661948008833GARYLINEFA340FA3402023-11-21
00661948004361GARYLINEDPPZ52DPPZ522023-11-20
00661948004385GARYLINEPZ52-CKPZ52-CK2023-11-09
00661948008840GARYLINEDPCT56TDPCT56T2023-10-26
00661948004057GARYLINEWFA2WFA12023-10-19
00661948009847GARYLINEWFA1WFA12023-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00049696295260THERA PlusFOURSTAR GROUP INC.OHO2026-06-09
00049696295277THERA PlusFOURSTAR GROUP INC.OHO2026-06-09
00049696295284THERA PlusFOURSTAR GROUP INC.OHO2026-06-09
00049696295291THERA PlusFOURSTAR GROUP INC.OHO2026-06-09
00049696295307THERA PlusFOURSTAR GROUP INC.OHO2026-06-09
00049696295314THERA PlusFOURSTAR GROUP INC.OHO2026-06-09
06953395551029JINGDIJINHUA JINGDI MEDICAL SUPPLIES CO.,LTDOHO2026-06-05
06975675784682Rhino RescueEMSRUN GROUPOHO2026-06-01
06975675788093Rhino RescueEMSRUN GROUPOHO2026-06-01
06975675788109Rhino RescueEMSRUN GROUPOHO2026-06-01
M6898143003020Maritime Boat Box - AdvancedSafeguard US Operating, LLCOHO2026-05-28
00842209138760NARNORTH AMERICAN RESCUE, LLCOHO2026-05-27
00842209138777NARNORTH AMERICAN RESCUE, LLCOHO2026-05-27
00842209138784NARNORTH AMERICAN RESCUE, LLCOHO2026-05-27
00842209138791NARNORTH AMERICAN RESCUE, LLCOHO2026-05-27
00842209138807NARNORTH AMERICAN RESCUE, LLCOHO2026-05-27
00842209138814NARNORTH AMERICAN RESCUE, LLCOHO2026-05-27
00842209138821NARNORTH AMERICAN RESCUE, LLCOHO2026-05-27
00842209138838NARNORTH AMERICAN RESCUE, LLCOHO2026-05-27
00842209138845NARNORTH AMERICAN RESCUE, LLCOHO2026-05-27
00842209138852NARNORTH AMERICAN RESCUE, LLCOHO2026-05-27
00842209138869NARNORTH AMERICAN RESCUE, LLCOHO2026-05-27
00842209138876NARNORTH AMERICAN RESCUE, LLCOHO2026-05-27
00842209138883NARNORTH AMERICAN RESCUE, LLCOHO2026-05-27
00842209138937NARNORTH AMERICAN RESCUE, LLCOHO2026-05-27
00842209138968NARNORTH AMERICAN RESCUE, LLCOHO2026-05-27
00842209138975NARNORTH AMERICAN RESCUE, LLCOHO2026-05-27
M6898444601190Mojo Multi Mission - AdvancedSafeguard US Operating, LLCOHO2026-05-27
B54133311420IFAKFARETEC, INC.OHO2026-05-12
00842209138678NARNORTH AMERICAN RESCUE, LLCOHO2026-05-12