FDA.reportPublic FDA data

Pivot Arm

Primary DI
00815212022821
Brand
Pivot Arm
Company
Izi Medical Products, LLC
Model
01-04724
Published
2017-02-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
KGXTape And Bandage, Adhesive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGXTape And Bandage, AdhesiveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815212022821PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815212022821008152120228218152120228210815212022821

GMDN Terms#

Term, Definition table
TermDefinition
Basic skin adhesive tapeA long and narrow flexible band of fabric, plastic, paper, or other material, coated on one or both sides with a pressure-sensitive adhesive, intended to non-invasively adhere to the skin surface to fix a dressing in place, or attach objects (e.g., catheter, lamp); it is not hypoallergenic or waterproof. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
933506164
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B8870010690X-MARK Ultra0010690010692022-06-17
EIBA10010X-Mark100110012016-09-23
EIBA10020X-Mark100210022016-09-23
EIBA10070X-MArk100710072016-09-23
EIBA10080X-Mark100810082016-09-23
EIBA10090X-Mark100910092016-09-23
EIBA10210X-Mark102110212016-09-23
EIBA10220X-Mark102210222016-09-23
EIBA10230X-Mark102310232016-09-23
EIBA10270X-Mark102710272016-09-23
EIBA10280X-Mark102810282016-09-23
EIBA10290X-Mark102910292016-09-23
EIBA10400X-Mark104010402017-03-16
EIBA10410X-Mark104110412016-09-23
EIBA10420X-Mark104210422016-09-23
EIBA10470X-Mark104710472016-09-23
EIBA10600X-Mark Ultra106010602016-09-23
EIBA10610X-Mark Ultra106110612016-09-23
EIBA10620X-Mark Ultra106210622016-09-23
EIBA10670X-Mark Ultra106710672016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09420012436047Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDKGX2026-04-14
09420012436061Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDKGX2026-04-14
10192253049817TelfaCardinal Health 200, LLCKGX2026-02-25
10192253050080TelfaCardinal Health 200, LLCKGX2026-02-25
10080196669523MEDLINEMEDLINE INDUSTRIES, INC.KGX2026-01-30
10080196669530MEDLINEMEDLINE INDUSTRIES, INC.KGX2026-01-30
10080196669547MEDLINEMEDLINE INDUSTRIES, INC.KGX2026-01-30
10618125192318AquaGuardTIDI PRODUCTS, LLCKGX2025-09-23
10198459392078MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KGX2025-07-07
10080196691708CURADMEDLINE INDUSTRIES, INC.KGX2025-05-23
10198459343506MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KGX2025-05-22
10192253050172TelfaCardinal Health 200, LLCKGX2025-04-18
10192253050189TelfaCardinal Health 200, LLCKGX2025-04-18
10385081120333Omnipod PodPalsInsulet CorporationKGX2025-04-16
10653160999003Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.KGX2025-04-07
10197106767726CARDINAL HEALTHCardinal Health 200, LLCKGX2024-10-31
10080196669417MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-07-31
10080196669493MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-07-31
10080196743032MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-07-31
09355751001259Seer HomeSEER MEDICAL HOLDINGS LIMITEDKGX2024-06-27
10197344102716MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10197344102723MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10197344102730MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10197344102747MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10197344102754MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10197344102761MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10197344102778MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10197344102785MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10192253046779KendallCardinal Health 200, LLCKGX2024-06-11
10192253046304KendallCardinal Health 200, LLCKGX2024-05-29