FDA.reportPublic FDA data

GARYLINE

Primary DI
00661948005368
Brand
GARYLINE
Company
Garyline LLC
Model
FA1239
Catalog number
FA1239
Published
2023-08-17
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
00661948005368PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00661948005368006619480053686619480053680661948005368

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
00661948011710GARYLINEPZ53-CK-2PZ53-CK-12024-03-05
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

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