Little PALS
GUDID 00851913006067
AXELGAARD MANUFACTURING CO., LTD.
Neonatal electrocardiographic electrode Neonatal electrocardiographic electrode Neonatal electrocardiographic electrode Neonatal electrocardiographic electrode Neonatal electrocardiographic electrode Neonatal electrocardiographic electrode Neonatal electrocardiographic electrode Neonatal electrocardiographic electrode Neonatal electrocardiographic electrode Neonatal electrocardiographic electrode Neonatal electrocardiographic electrode Neonatal electrocardiographic electrode Neonatal electrocardiographic electrode Neonatal electrocardiographic electrode Neonatal electrocardiographic electrode Neonatal electrocardiographic electrode| Primary Device ID | 00851913006067 |
| NIH Device Record Key | b4b9f39d-8a87-40f8-b207-a5318f1ef163 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Little PALS |
| Version Model Number | SEN1003 |
| Company DUNS | 150959401 |
| Company Name | AXELGAARD MANUFACTURING CO., LTD. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00851913006067 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K000206
FDA Product Code
| DRX | Electrode, Electrocardiograph |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-03-31 |
On-Brand Devices [Little PALS]
| 00851913006111 | SEN5001 |
| 00851913006104 | SEN4001 |
| 00851913006098 | SEN3001 |
| 00851913006081 | SEN2002 |
| 00851913006074 | SEN2001 |
| 00851913006067 | SEN1003 |
Trademark Results [Little PALS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LITTLE PALS 73396879 1269177 Dead/Cancelled |
Americana Trading, Inc. 1982-09-30 |
 LITTLE PALS 73396878 not registered Dead/Abandoned |
AMERICANA TRADING, INC. 1982-09-30 |
 LITTLE PALS 73396877 1269323 Dead/Cancelled |
Americana Trading, Inc. 1982-09-30 |
 LITTLE PALS 73264553 1170426 Dead/Cancelled |
Animal Fair, Inc. 1980-06-02 |
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