VIveCare

GUDID 10810113578467

Electric Breast Pump (Dual)

VIVE HEALTH LLC

Breast pump, electric
Primary Device ID10810113578467
NIH Device Record Keyd7e86881-a05d-461b-8cd0-50230395516b
Commercial Distribution StatusIn Commercial Distribution
Brand NameVIveCare
Version Model NumberLVA3076WHT
Company DUNS047025993
Company NameVIVE HEALTH LLC
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100810113578460 [Primary]
GS110810113578467 [Package]
Contains: 00810113578460
Package: Case [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HGXPump, Breast, Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-09-12
Device Publish Date2024-09-04

On-Brand Devices [VIveCare]

10810041989755Surgical Tape (4")
00810041989741Surgical Tape (2")
10850041211036Hydrocolloid Bordered Dressing 6"
10810041989878Calcium Alginate Dressing 4"
10810041989861Calcium Alginate Dressing 2"
10810041989854Hydrocolloid Bordered Dressing 4"
10810041989830Silver Alginate Dressing 4"
10810041989823Silicone Foam Dressing 6"
10810041989816Silicone Foam Dressing 4"
10810041989809Silicone Foam Dressing 3"
10810041989793Transparent Adhesive Bandage 8"
10810041989786Transparent Adhesive Bandage 6"
10810041989779Transparent Adhesive Bandage 4"
10810041989762Transparent Adhesive Bandage 2"
10810041989939Gauze Pads (Sterile) 4"
10810041989922Gauze Pads (Sterile) 3"
10810041989915Gauze Roll Sterile (4")
10810041989908Gauze Roll Sterile (3")
10850041211715Cohesive Bandage (Large)
10850041211708Cohesive Bandages (Small)
10810041989977Elastic Bandages (XL)
10810041989960Elastic Bandage (Large)
10810041989953Elastic Bandage (Medium)
10810041989946Elastic Bandages (Small)
10810113572267Island Dressing (White) 4x10"
10810113572250Island Dressing (White) 4x8"
10810113572243Island Dressing (White) 2x2"
10810113572236Silicone Foam Dressing (Tan) 7x7"
10810113572229Silicone Foam Dressing (Tan) 4x10"
00810113572215Silicone Foam Dressing (Tan) 4x8"
10810113572205Silicone Foam Dressing (Tan) 2x2"
10810113572120Elastic Tubular Bandage 4.7"
10810113572113Elastic Tubular Bandage 4"
10810113572106Elastic Tubular Bandage 3.4"
10810113572090Elastic Tubular Bandage 3"
10810113574612Wound Closure Kit
00810041989840Silver Alginate Dressing 2"
10810113577507Hydrodgel Wound Gel (3oz) 2PK
10810113577491Hydrodgel Wound Gel (3oz)
10810113576753Scar Tape
10810113576692Silver Anti-Microbial Wound Gel
10810113576494Transparent FIlm Dressing (6x8")
10810113576487Transparent Film Dressing (4 x 4 3/4")
10810113576470Transparent Film Dressing (2 3/8' x 2 3/4")
10810113577125Ostomy Bags Two-Piece (Closed) 21PK
10810113577118Ostomy Bags Two-Piece (Clamp) 21PK
10810113577101Ostomy Bags Two-Piece (Hook and Loop) 21PK
10810113577026Ostomy Bag 1-piece (Closed) 20PK
10810113577019Ostomy Bags 1-piece (Clamp) 20PK
10810113577002Ostomy Bags 1-piece (Hook and Loop) 20PK

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