FDA.reportPublic FDA data

Ultradrape

Primary DI
20855683006542
Brand
Ultradrape
Company
PARKER LABORATORIES INC
Model
34-15
Device description
Ultrasound Guided Peripheral Intravenous Barrier and Securement Device 3.25''x5.8''
Published
2023-09-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
GYBMedia, Electroconductive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GYBMedia, ElectroconductiveNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K780973000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K780973000SIGNAPADParker Laboratories, Inc.1978-07-27GYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20855683006542PackageGS11In Commercial Distribution
10855683006545PrimaryGS10
00855683006548Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2085568300654220855683006542
1085568300654510855683006545
00855683006548008556830065488556830065480855683006548

GMDN Terms#

Term, Definition table
TermDefinition
Electrode conductive mediumA non-sterile substance intended to be used as a medium for the efficient transmission of electrical signals between an electrode and the body, and for the reduction of the isolation properties of the skin. It is typically in the form of a gel, paste, spray or cream and is usually used in electrocardiography, defibrillation and diathermy. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9732769500customerservice@parkerlabs.com

Regulatory Flags#

DUNS number
002449593
Device count
50
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00303410000012AquaflexULTRASOUND GEL PAD 04-92-8203112025-05-30
00303410000029AquaflexULTRASOUND GEL PAD 04-90-8203112024-08-28
00303410000036AquaflexULTRASOUND GEL PAD 04-95-8203112024-11-20
00855683006579Delphinus Sequr™ Breast Interface99-176-7809622023-01-24
10855683006576Delphinus Sequr™ Breast Interface99-176-7809622023-01-24
20855683006023STERILE AQUASONICULTRASOUND TRANSMISSION GEL01-01-42016-12-19
00855683006005STERILE AQUASONICULTRASOUND TRANSMISSION GEL01-012016-12-19
10303410000019AquaflexULTRASOUND GEL PAD 04-92-8203112025-05-30
10855683006965ULTRADRAPE 2Ultrasound Guided Peripheral Intravenous Barrier a34-102025-05-20
20855683006962ULTRADRAPE 2Ultrasound Guided Peripheral Intravenous Barrier a34-102025-05-20
10303410000033AquaflexULTRASOUND GEL PAD 04-95-8203112024-11-20
10303410000026AquaflexULTRASOUND GEL PAD 04-90-8203112024-08-28
10855683006866Eclipse Probe Cover38-01-12021-12-31
00855683006739Timm Medical57-05-1447382019-11-11
10855683006347ECLIPSEPROBE COVER-LATEX FREE38-012016-12-19
10855683006354ECLIPSEPROBE COVER-LATEX FREE38-032016-12-19
10855683006361AQUAGELLUBRICATING GEL57-052016-12-19
00855683006371AQUAGELLUBRICATING GEL57-202016-12-19
10855683006545Ultradrape34-152023-09-18
10855683006910BrainScope99-1000-0042023-09-18

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00197998355417Solventum™Solventum US LLCGYB2026-02-15
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