| Primary Device ID | 00080529510112 |
| NIH Device Record Key | f96801ed-39ad-4cfb-b637-f0177455503f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | INFANT E-A-RTIP |
| Version Model Number | 420-2095 |
| Catalog Number | 420-2095 |
| Company DUNS | 078763316 |
| Company Name | 3M COMPANY |
| Device Count | 20 |
| 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 | 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 | false |
| Phone | +1(888)733-4512 |
| 3Mhealthcarecompliance@mmm.com | |
| Phone | +1(888)733-4512 |
| 3Mhealthcarecompliance@mmm.com | |
| Phone | +1(888)733-4512 |
| 3Mhealthcarecompliance@mmm.com | |
| Phone | +1(888)733-4512 |
| 3Mhealthcarecompliance@mmm.com | |
| Phone | +1(888)733-4512 |
| 3Mhealthcarecompliance@mmm.com | |
| Phone | +1(888)733-4512 |
| 3Mhealthcarecompliance@mmm.com | |
| Phone | +1(888)733-4512 |
| 3Mhealthcarecompliance@mmm.com | |
| Phone | +1(888)733-4512 |
| 3Mhealthcarecompliance@mmm.com | |
| Phone | +1(888)733-4512 |
| 3Mhealthcarecompliance@mmm.com | |
| Phone | +1(888)733-4512 |
| 3Mhealthcarecompliance@mmm.com | |
| Phone | +1(888)733-4512 |
| 3Mhealthcarecompliance@mmm.com | |
| Phone | +1(888)733-4512 |
| 3Mhealthcarecompliance@mmm.com | |
| Phone | +1(888)733-4512 |
| 3Mhealthcarecompliance@mmm.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00051131273269 [Unit of Use] |
| GS1 | 00080529510112 [Primary] |
| ETT | CUSHION, EARPHONE (FOR AUDIOMETRIC TESTING) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-24 |
| 00080529510112 | 3M(TM) Infant Eartip 4.0mm 420-2095-5, 10 pair/case |
| 00080529510105 | 3M(TM) Infant Eartip 3.5mm 420-2094-5, 10 pair/case |