Primary Device ID | 00810117140793 |
NIH Device Record Key | 4da72bf1-b043-442d-899e-4bcaf9b3308c |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Kaye Products - W1BHSX |
Version Model Number | W1BHSX |
Company DUNS | 082364654 |
Company Name | Kaye Products, Inc. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | true |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00810117140793 [Primary] |
ITJ | Walker, Mechanical |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-07-13 |
Device Publish Date | 2023-07-05 |
00810117140007 - Kaye Products, W1/2B | 2023-07-13 Sm Child's Posture Control Walker/Gait Trainer, 2 wheels |
00810117140014 - Kaye Products - W1/2BR | 2023-07-13 Small Child's Posture Control Walker/Gait Trainer. 4 Wheels |
00810117140021 - Kaye Products - W1/2BS | 2023-07-13 Small Child's Posture Control Walker/Gait Trainer. 4 Wheels, Front Swivel |
00810117140076 - Kaye Products - W1/2BRX | 2023-07-13 Small Child's Posture Control Walker /Gait Trainer /4 wheels/Rear Silent |
00810117140083 - Kaye Products - W1/2BSX | 2023-07-13 Small Child's Posture Control Walker/Gait Trainer /Front Swivel/Rear Silent |
00810117140090 - Kaye Products - W1B | 2023-07-13 Child's Posture Control Walker/Gait Trainer, 2 Wheels |
00810117140106 - Kaye Products - W1BR | 2023-07-13 Child's Posture Control Walker/Gait Trainer, 4 Wheels |
00810117140113 - Kaye Products - W1BS | 2023-07-13 Child's Posture Control Walker/Gait Trainer, 4 Wheels/Front Swivel |