| Primary Device ID | 10889483228654 |
| NIH Device Record Key | 3f18393f-6030-4160-896c-1a1f7c16f709 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Strapette™ |
| Version Model Number | CP-4404 |
| Catalog Number | CP-4404 |
| Company DUNS | 069009268 |
| Company Name | SUNMED, LLC |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 1-800-433-2797 |
| info@sun-med.com | |
| Phone | 1-800-433-2797 |
| info@sun-med.com | |
| Phone | 1-800-433-2797 |
| info@sun-med.com | |
| Phone | 1-800-433-2797 |
| info@sun-med.com | |
| Phone | 1-800-433-2797 |
| info@sun-med.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00709078013072 [Previous] |
| GS1 | 10889483228654 [Primary] |
| GS1 | 20889483228651 [Package] Package: Box [40 Units] In Commercial Distribution |
| JAY | Support, Breathing Tube |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-23 |
| Device Publish Date | 2025-12-15 |
| 10889483228661 | Pediatric Strapette™ with Large Tube Tackles |
| 10889483228654 | Neonatal Strapette™ with Large Tube Tackles |
| 10889483228616 | Pediatric Strapette™ with Small Tube Tackles |
| 10889483228609 | Neonatal Strapette™ with Small Tube Tackles |