AuraFlex 327250000U
GUDID 05707480037810
Ambu Auraflex U Size 2.5
Ambu A/S
Laryngeal mask airway, single-use| Primary Device ID | 05707480037810 |
| NIH Device Record Key | 0c5d639c-e362-4b6f-a01b-11bdc88e680c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AuraFlex |
| Version Model Number | 327250000U |
| Catalog Number | 327250000U |
| Company DUNS | 305682023 |
| Company Name | Ambu A/S |
| 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 | 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
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05707480037797 [Package] Contains: 05707480037803 Package: [10 Units] In Commercial Distribution |
| GS1 | 05707480037803 [Primary] |
| GS1 | 05707480037810 [Package] Contains: 05707480037797 Package: [12 Units] In Commercial Distribution |
FDA Product Code
| CAE | AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-03-10 |
| Device Publish Date | 2023-03-02 |
On-Brand Devices [AuraFlex]
| 05707480037810 | Ambu Auraflex U Size 2.5 |
| 05707480037919 | Ambu Auraflex U Size 6 |
| 05707480037902 | Ambu Auraflex U Size 5 |
| 05707480037858 | Ambu Auraflex U Size 4 |
| 05707480037841 | Ambu Auraflex U Size 3 |
| 05707480037766 | Ambu Auraflex U Size 2 |
Trademark Results [AuraFlex]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AURAFLEX 75599780 2316249 Dead/Cancelled |
Alfa Biotech S.p.A. 1998-12-04 |
 AURAFLEX 74130574 1732399 Dead/Cancelled |
THERIAK S.A. 1991-01-15 |
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