Primary Device ID | 46923980115156 |
NIH Device Record Key | 344a30c2-4f1d-4d1b-8896-cc985b0b9119 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | N/A |
Version Model Number | AB0437 |
Company DUNS | 527333326 |
Company Name | GaleMed Xiamen Co., Ltd. |
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 | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | true |
RX Perscription | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 06923980115158 [Primary] |
GS1 | 46923980115156 [Package] Contains: 06923980115158 Package: carboard [15 Units] In Commercial Distribution |
CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-09-05 |
Device Publish Date | 2025-08-28 |
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06923980101922 | Guedel Airway 8cm, Green |
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46923980115187 | Anesthesia Circuit, Adult, 1.8m |
46923980115170 | Anesthesia Circuit, Adult, 1.2m |
46923980115163 | Coaxial Circuit, Adult, 1.8m |
46923980115156 | Anesthesia Circuit, Adult, 1.5m |
46923980110502 | CPAP Face Mask Set w/Hose, S |
46923980110496 | CPAP Face Mask Set w/Hose, M |
46923980104747 | CPAP Face Mask Set w/Hose, L |