FDA.reportPublic FDA data

Dale IV Line Manager

Primary DI
00817612021114
Brand
Dale IV Line Manager
Company
Dale Medical Products, Inc.
Model
630
Catalog number
630
Device description
The Dale IV Line Manager is a foam device used to separate and organize up to 6 IV Lines
Published
2025-08-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
PUKAdministration Set Securement Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PUKAdministration Set Securement DeviceGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817612021114PackageGS110In Commercial Distribution
00817612021107PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817612021114008176120211148176120211140817612021114
00817612021107008176120211078176120211070817612021107

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
001061233
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
H84101501Dale Foley Catheter Holder1501502018-08-30
H84103161Dale Foley Catheter Holder3163162018-08-30
H84103301Dale Foley Catheter Holder3303302018-08-30
H84104901Dale Urodynamic Tube Holder4904902018-08-30
00817612020001Dale General Purpose Securement Device9529522018-09-10
00817612020025Dale Catheter Securement Device8538532018-09-10
00817612020124Dale Catheter Securement Device8508502018-09-10
00817612020148Dale Catheter Securement Device8518512018-09-10
00817612020162Dale Catheter Securement Device8528522018-09-10
00817612020186Dale Catheter Securement Device8548542018-09-10
00817612020209Dale General Purpose Securement Device9509502018-09-10
00817612020223Dale General Purpose Securement Device9519512018-09-10
00817612020902Dale Catheter Securement Device8498492018-09-10
00817612020926Dale Catheter Securement Device8488482018-10-10
00817612021107Dale IV Line Manager6306302025-08-11
00817612020544Dale Foley Catheter Holder1501502019-03-18
00817612020568Dale Foley Catheter Holder3163162019-03-18
00817612020582Dale Foley Catheter Holder3303302019-03-18
00817612021121Dale Airway Holder2602602026-03-11
00817612021053Dale Post Surgical Compression Bra7127122025-03-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290013484871EQUASHIELD CSTDEQUASHIELD MEDICAL LTDPUK2026-05-26
00817612021107Dale IV Line ManagerDale Medical Products, Inc.PUK2025-08-11
M7525250360STRADIS HEALTHCARESTRADIS MEDICAL, LLCPUK2022-03-15
00860007083105IVY LOCEdzway LLCPUK2021-10-23
20634624100606Qlinch Securement BandQUEST MEDICAL INCPUK2020-04-08
00634624100602Qlinch Securement BandQUEST MEDICAL INCPUK2020-04-08