AquaFlate

Primary DI
50851809002871
Brand
AquaFlate
Company
HR PHARMACEUTICALS INC.
Model
255
Catalog number
255
Device description
AquaFlate 5mL Pre-Filled Sterile Water Syringe
Published
2023-05-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EZLCATHETER, RETENTION TYPE, BALLOON

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EZLCatheter, Retention Type, BalloonGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50851809002871PackageGS1400In Commercial Distribution
00851809002876PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5085180900287150851809002871
00851809002876008518090028768518090028760851809002876

GMDN Terms#

Term, Definition table
TermDefinition
Device-irrigation sterile waterA fluid consisting of sterile water (H2O) that is used exclusively for the cleaning and irrigation of a device (e.g., a Foley catheter or a tracheobronchial suction catheter). It is not intended for wound irrigation or injection or intravenous (IV) administration. The device is usually available in a plastic container or bottle of various sizes. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(717)252-1110sbenser@hrpharma.com

Regulatory Flags#

DUNS number
828918164
Device count
1
DM exempt
false
Premarket exempt
false
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
00851809002012HR Lubricating Jelly2012012018-08-27
00851809002036HR Lubricating Jelly2032032018-08-29
00851809002432Surgilube2810205122810205122018-08-27
00851809002456Surgilube2810205372810205372018-08-27
00850067913023TruCath®FP12026-07-23
00850045818494TruCath OasisRH08162023-06-23
00850045818500TruCath OasisRH10162023-06-23
00850045818517TruCath OasisRH12162023-06-23
00850045818524TruCath OasisRH14162023-06-23
00850045818531TruCath OasisRH16162023-06-23
00850045818548TruCath OasisRH18162023-06-23
00850045818555TruCath OasisRH1016C2023-06-23
00850045818562TruCath OasisRH1216C2023-06-23
00850045818579TruCath OasisRH1416C2023-06-23
00850045818586TruCath OasisRH1616C2023-06-23
00850045818593TruCath OasisRH08062023-06-23
00850045818609TruCath OasisRH10062023-06-23
00850045818616TruCath OasisRH12062023-06-23
00850045818623TruCath OasisRH14062023-06-23
00850045818630TruCath OasisRH16062023-06-23

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Primary DI, Brand, Company table
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08886483507487Silicone Foley CatheterBIOPTIMAL INTERNATIONAL PTE. LTD.EZL2026-05-04
08886483507494Silicone Foley CatheterBIOPTIMAL INTERNATIONAL PTE. LTD.EZL2026-05-04
10192253068221DoverCardinal Health 200, LLCEZL2026-01-15
10192253068238DoverCardinal Health 200, LLCEZL2026-01-15
10192253067651DoverCardinal Health 200, LLCEZL2025-04-14
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10192253031423DoverCardinal Health 200, LLCEZL2025-01-15
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