FDA.report

Vive

Primary DI
10810041989441
Brand
Vive
Company
VIVE HEALTH LLC
Model
LVA2103PAK24
Device description
Bed Pan Liner (24PK)
Published
2023-11-13
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

Related Records

Product Codes

CodeName
FOBBedpan

Product Code Classifications

CodeDeviceSpecialtyClass
FOBBedpanGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10810041989441PackageGS19In Commercial Distribution
00810041989444PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1081004198944110810041989441
00810041989444008100419894448100419894440810041989444

GMDN Terms

TermDefinition
Bedpan linerA device intended to be fitted into and line a bedpan, or related device, to collect waste during use and thereby function as a disposable physical barrier to reduce/prevent cross-contamination between patients using the bedpan. It is typically designed as a shaped bowl-like container with a rim made of disposable materials. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
047025993
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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 DIBrandModelCatalogPublished
00810178883943ViveSUP3111BLK2026-03-06
00810178884506ViveMOB1141BLK322026-03-06
00810178884643ViveMOB1142BLK2026-03-06
00810178884766ViveMOB1144GRY2026-03-06
00810178884773ViveMOB1144BLU2026-03-06
00810178884780ViveMOB1144PNK2026-03-06
00810178885213ViveMOB1139BLK262026-03-06
00810178885220ViveMOB1139BLK282026-03-06
00810178885237ViveMOB1139BLK302026-03-06
00810178887040ViveLVA1004DBLU2026-03-06
00810178887057ViveLVA2030DBLU2026-03-06
00810178887392Vive MobilityMOB1079GRY2026-02-18
00810178886890ViveSUP2019BGEXS2026-02-17
00810178886906ViveSUP2019BGES2026-02-17
00810178886913ViveSUP2019BGEM2026-02-17
00810178886920ViveSUP2019BGEL2026-02-17
00810178886937ViveSUP2019BGEXL2026-02-17
00810178886944ViveSUP2019BLKXS2026-02-17
00810178886951ViveSUP2019BLKS2026-02-17
00810178886968ViveSUP2019BLKM2026-02-17

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10818323021759ViveVIVE HEALTH LLCFOB2024-01-12
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10810041989724ViveVIVE HEALTH LLCFOB2023-11-13
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00733657188370BARIATRIC BED PANALIMED, INC.FOB2022-12-01
00733657231618COMFORTABLE BED PANALIMED, INC.FOB2022-12-01