FDA.reportPublic FDA data

PREMIER VALUE

Primary DI
00840986016547
Brand
PREMIER VALUE
Company
PHARMACY VALUE ALLIANCE, LLC
Model
97205CD
Device description
PVA ASSORT FINGER COVERS
Published
2020-09-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NADDressing, Wound, Occlusive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NADDressing, Wound, OcclusiveGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840986016544PackageGS112Not in Commercial Distribution
20840986016541PackageGS16Not in Commercial Distribution
00840986016547PrimaryGS10
48409860165438Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084098601654410840986016544
2084098601654120840986016541
00840986016547008409860165478409860165470840986016547
4840986016543848409860165438

GMDN Terms#

Term, Definition table
TermDefinition
Finger-cot surgical drapeA protective covering made of latex designed to isolate a urological/gynaecological surgical site from contamination (e.g., microbial, substance), that has a projection (finger cot) retained within the rectum or vagina to allow repeated insertion of the surgeon's finger into the rectum (e.g., during a transurethral prostatectomy) or vagina, keeping the glove of the surgeon from being contaminated. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
952-890-1940UDI@APOTHECARYPRODUCTS.COM

Regulatory Flags#

DUNS number
089138159
Device count
30
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
false
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840986015854PREMIER VALUEF408-150CD2020-09-21
00840986016196Premier Value TamponsBPVAR402016-09-20
00840986016202Premier Value TamponsBPVAS402016-09-20
00840986016219Premier Value TamponsBPVAP402016-09-20
00840986016431PREMIER VALUE71091CD2020-09-21
00840986016516PREMIER VALUE67830CD2020-09-21
00840986016639Premier ValueOne Step Pregnancy Test2016-08-30
00840986016646Premier ValueOne Step Pregnancy Test2016-08-30
00840986016684Premier Value Unilet LancetsAT 0575CDC2023-01-06
00840986021091Premier ValueEarly Result Pregnancy Test2016-08-30
00840986026850Premier Value TamponsBPVGS182016-09-20
00840986026867Premier Value TamponsBPVGC362016-09-20
00840986030123Premier Value30122017-06-23
00840986032837Premier Value Unilet LancetsAT 0585CDC2023-01-06
00840986034992Premier Value AutoletAT 0270CDC2023-02-03
00840986036781CDC- Premier Value- 33G x 4mm pen needles w/removerAN 3860CDCAN 3860CDC2021-05-25
00840986037009Premier ValueOne Step Pregnancy Test2020-09-21
00840986010095PREMIER93965HZ93965HZ2016-09-20
00840986023675CDC - Premier Value - 31Gx6mm pen needles w/removerAN 3890CDCAN 3890CDC2016-09-19
00840986023682CDC - Premier Value - 31Gx8mm pen needles w/removerAN 3830CDCAN 3830CDC2016-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850088144215CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-08
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00850088144239CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-08
00850088144246CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-08
00850088144253CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-08
00850088144000CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-03
00850088144017CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-03
00850087488686CeeportCEEPORT INC.NAD2026-06-30
06970206823946Dr Perfect Hydrocolloid DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22
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06970206827067Ourmed Foam DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22
06970206827074Ourmed Foam DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22
06970206827081Ourmed Foam DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22
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06970206828149Ourmed Foam DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22
06970206828156Ourmed Foam DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22
06970206828163Ourmed Foam DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22
06970206828170Ourmed Foam DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22
10885632506000HalyardOWENS & MINOR DISTRIBUTION, INC.NAD2026-06-05
10885632506017HalyardOWENS & MINOR DISTRIBUTION, INC.NAD2026-06-05
10885632506024HalyardOWENS & MINOR DISTRIBUTION, INC.NAD2026-06-05
00850087488280CeeportCEEPORT INC.NAD2026-05-29
00850087488297CeeportCEEPORT INC.NAD2026-05-29
00850087488365CeeportCEEPORT INC.NAD2026-05-29
00850087488372CeeportCEEPORT INC.NAD2026-05-29
00850087488396CeeportCEEPORT INC.NAD2026-05-29